The following data is part of a premarket notification filed by Healthdyne, Inc. with the FDA for Healthdyne Impluse Ventilator.
| Device ID | K853300 |
| 510k Number | K853300 |
| Device Name: | HEALTHDYNE IMPLUSE VENTILATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | HEALTHDYNE, INC. 1850 PARKWAY PLACE, 12TH FLOOR Marietta, GA 30067 -8274 |
| Contact | William H Duffell |
| Correspondent | William H Duffell HEALTHDYNE, INC. 1850 PARKWAY PLACE, 12TH FLOOR Marietta, GA 30067 -8274 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-06 |
| Decision Date | 1985-08-15 |