The following data is part of a premarket notification filed by King Systems Corp. with the FDA for King Systems, Breathing Bag.
| Device ID | K880680 |
| 510k Number | K880680 |
| Device Name: | KING SYSTEMS, BREATHING BAG |
| Classification | Bag, Reservoir |
| Applicant | KING SYSTEMS CORP. 15011 HERRIMAN BLVD. P.O. BOX 1138 Noblesville, IN 46060 |
| Contact | Linda L Nordlund |
| Correspondent | Linda L Nordlund KING SYSTEMS CORP. 15011 HERRIMAN BLVD. P.O. BOX 1138 Noblesville, IN 46060 |
| Product Code | BTC |
| CFR Regulation Number | 868.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-19 |
| Decision Date | 1988-03-03 |