The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Argyle Cpap Nasal Cannula.
| Device ID | K811409 |
| 510k Number | K811409 |
| Device Name: | ARGYLE CPAP NASAL CANNULA |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | SHERWOOD MEDICAL CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-05-19 |
| Decision Date | 1981-06-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884527007117 | K811409 | 000 |
| 20884527007100 | K811409 | 000 |
| 20884527007094 | K811409 | 000 |
| 20884527007087 | K811409 | 000 |
| 20884527007070 | K811409 | 000 |
| 20884527007063 | K811409 | 000 |