The following data is part of a premarket notification filed by Spiracle Technology with the FDA for Spiracle Technology - Model 302 Ox Inhalator.
| Device ID | K963755 |
| 510k Number | K963755 |
| Device Name: | SPIRACLE TECHNOLOGY - MODEL 302 OX INHALATOR |
| Classification | Valve, Non-rebreathing |
| Applicant | SPIRACLE TECHNOLOGY 16912 VON KARMAN AVE. Irvine, CA 92606 -4923 |
| Contact | George P Messing |
| Correspondent | George P Messing SPIRACLE TECHNOLOGY 16912 VON KARMAN AVE. Irvine, CA 92606 -4923 |
| Product Code | CBP |
| CFR Regulation Number | 868.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-18 |
| Decision Date | 1997-04-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814940020208 | K963755 | 000 |