PMBClass II
External Airway
21 CFR 868.5105 / Anesthesiology
PMB is the FDA product code for External Airway, a class II device type, regulated under 21 CFR 868.5105. FDA's definition for this code reads: "This device is intended to maintain airway patency using negative pressure during mild to moderate sedation". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- PMB
- Device name
- External Airway
- FDA definition
- This device is intended to maintain airway patency using negative pressure during mild to moderate sedation.
- Regulation
- 21 CFR 868.5105
- Device class
- Class II
- Review panel
- Anesthesiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code PMB
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2015 | 1 |
Applicants with the most clearances
Product code PMB| Applicant | Clearances |
|---|---|
| Sommetrics | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code PMB.
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