The following data is part of a premarket notification filed by King Systems Corp. with the FDA for K.p.r. (king Personal Resuscitator).
| Device ID | K943402 |
| 510k Number | K943402 |
| Device Name: | K.P.R. (KING PERSONAL RESUSCITATOR) |
| Classification | Valve, Non-rebreathing |
| Applicant | KING SYSTEMS CORP. 15011 HERRIMAN BLVD. P.O. BOX 1138 Noblesville, IN 46060 |
| Contact | Michael A Leagre |
| Correspondent | Michael A Leagre KING SYSTEMS CORP. 15011 HERRIMAN BLVD. P.O. BOX 1138 Noblesville, IN 46060 |
| Product Code | CBP |
| CFR Regulation Number | 868.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-14 |
| Decision Date | 1994-08-19 |