Cerebral Assessment Systems, Inc.: FDA clearances and approvals
Cerebral Assessment Systems, Inc. has 0 FDA 510(k) clearances, plus 1 De Novo decision, across 1 product code in 1 review panel.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PKQ | Computerized Cognitive Assessment Aid | 1 | 0 |
Review panels
- Neurology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN130033 | De Novo | Computerized Cognitive Assessment Aid | 2015-06-05 |
Recalls
openFDA lists no recalls under a recalling firm named Cerebral Assessment Systems, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Cerebral Assessment Systems, Inc. have?
Cerebral Assessment Systems, Inc. has 0 FDA 510(k) clearances, plus 1 De Novo decision, across 1 product code in 1 review panel.
What devices does Cerebral Assessment Systems, Inc. make?
Its most frequent FDA product codes are PKQ (Computerized Cognitive Assessment Aid, 1).
Has Cerebral Assessment Systems, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Cerebral Assessment Systems, Inc. Related entities may recall under other names.
Next steps
- See all 0 Cerebral Assessment Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code PKQ, Cerebral Assessment Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.