The following data is part of a premarket notification filed by Respan Products, Inc. with the FDA for Jemsdal Mask.
| Device ID | K942907 |
| 510k Number | K942907 |
| Device Name: | JEMSDAL MASK |
| Classification | Mask, Oxygen |
| Applicant | RESPAN PRODUCTS, INC. VITAID, LTD 240 PORTAGE ROAD Lewiston, NY 14092 -0670 |
| Product Code | BYG |
| CFR Regulation Number | 868.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-21 |
| Decision Date | 1994-08-31 |