The following data is part of a premarket notification filed by Zefon Medical Products with the FDA for Rebreather Bags.
| Device ID | K940220 |
| 510k Number | K940220 |
| Device Name: | REBREATHER BAGS |
| Classification | Bag, Reservoir |
| Applicant | ZEFON MEDICAL PRODUCTS 5350 SOUTHWEST FIRST LN. Ocala, FL 34474 |
| Contact | Robert L Stone,jr |
| Correspondent | Robert L Stone,jr ZEFON MEDICAL PRODUCTS 5350 SOUTHWEST FIRST LN. Ocala, FL 34474 |
| Product Code | BTC |
| CFR Regulation Number | 868.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-21 |
| Decision Date | 1994-05-27 |