The following data is part of a premarket notification filed by Healthdyne, Inc. with the FDA for Infant Ventilator, (respirator) Plan B.
| Device ID | K802583 |
| 510k Number | K802583 |
| Device Name: | INFANT VENTILATOR, (RESPIRATOR) PLAN B |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | HEALTHDYNE, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-10-20 |
| Decision Date | 1980-12-18 |