FDA product code MMH: Blood Establishment Computer Software And Accessories
MMH is the FDA product code for blood establishment computer software and accessories. It is a Class II device, regulated under 21 CFR 864.9165 and reviewed by the Hematology panel. Devices under MMH reach the market by 510(k); FDA lists no cleared 510(k)s for it. FDA has posted 2 recalls for MMH devices.
Classification
| Field | Value |
|---|---|
| Device name | Blood Establishment Computer Software And Accessories |
| Device class | Class II |
| Regulation | 21 CFR 864.9165 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
Recalls for MMH devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-04-25.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code MMH?
MMH is the FDA product code for blood establishment computer software and accessories. It is a Class II device, regulated under 21 CFR 864.9165 and reviewed by the Hematology panel.
What device class is MMH?
Class II, regulation 21 CFR 864.9165. Typical premarket route: 510(k).
Have MMH devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2018-04-25.
Next steps
- Run an FDA pathway report with predicate devices for product code MMH
- Run a recall and safety report across every MMH manufacturer
- Watch product code MMH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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