FDA product code MVH: Device, Detection, Sulfide
MVH is the FDA product code for device, detection, sulfide. It is a Class II device, regulated under 21 CFR 872.1870 and reviewed by the Dental panel. Devices under MVH reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it. FDA has posted 1 recall for MVH devices.
Classification
| Field | Value |
|---|---|
| Device name | Device, Detection, Sulfide |
| Device class | Class II |
| Regulation | 21 CFR 872.1870 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for MVH devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2005-07-29.
Frequently asked questions
What is FDA product code MVH?
MVH is the FDA product code for device, detection, sulfide. It is a Class II device, regulated under 21 CFR 872.1870 and reviewed by the Dental panel.
What device class is MVH?
Class II, regulation 21 CFR 872.1870. Typical premarket route: 510(k).
Have MVH devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2005-07-29.
Next steps
- Run an FDA pathway report with predicate devices for product code MVH
- Run a recall and safety report across every MVH manufacturer
- Watch product code MVH 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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