The following data is part of a premarket notification filed by Healthdyne Technologies, Inc. with the FDA for Nasal Interface Model 7910.
| Device ID | K974453 |
| 510k Number | K974453 |
| Device Name: | NASAL INTERFACE MODEL 7910 |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | HEALTHDYNE TECHNOLOGIES, INC. 1255 KENNESTONE CIR. Marietta, GA 30066 |
| Contact | Betty Cortelloni |
| Correspondent | Betty Cortelloni HEALTHDYNE TECHNOLOGIES, INC. 1255 KENNESTONE CIR. Marietta, GA 30066 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-25 |
| Decision Date | 1998-08-04 |