The following data is part of a premarket notification filed by Breathing Technologies Corp. with the FDA for Nasal Aire.
| Device ID | K990659 |
| 510k Number | K990659 |
| Device Name: | NASAL AIRE |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | BREATHING TECHNOLOGIES CORP. 11000 WESTON PKWY. Cary, NC 27709 |
| Contact | Terry C Mcmahaon |
| Correspondent | Terry C Mcmahaon BREATHING TECHNOLOGIES CORP. 11000 WESTON PKWY. Cary, NC 27709 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-01 |
| Decision Date | 1999-11-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10607411944083 | K990659 | 000 |
| 10607411944076 | K990659 | 000 |
| 10607411944069 | K990659 | 000 |
| 10607411944052 | K990659 | 000 |
| 10607411944045 | K990659 | 000 |