The following data is part of a premarket notification filed by Life Design Systems, Inc. with the FDA for Anesthesia Breathing Bag, Various Sizes.
| Device ID | K822116 |
| 510k Number | K822116 |
| Device Name: | ANESTHESIA BREATHING BAG, VARIOUS SIZES |
| Classification | Bag, Reservoir |
| Applicant | LIFE DESIGN SYSTEMS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | BTC |
| CFR Regulation Number | 868.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-07-19 |
| Decision Date | 1982-08-16 |