The following data is part of a premarket notification filed by Hudson Oxygen Therapy Sales Co. with the FDA for Infant Percussor #5534.
| Device ID | K812803 |
| 510k Number | K812803 |
| Device Name: | INFANT PERCUSSOR #5534 |
| Classification | Percussor, Powered-electric |
| Applicant | HUDSON OXYGEN THERAPY SALES CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | BYI |
| CFR Regulation Number | 868.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-10-06 |
| Decision Date | 1981-12-03 |