The following data is part of a premarket notification filed by Respiratory Support Products, Inc. with the FDA for Gas Sampling Kit Modification.
| Device ID | K921510 |
| 510k Number | K921510 |
| Device Name: | GAS SAMPLING KIT MODIFICATION |
| Classification | Set, Tubing And Support, Ventilator (w Harness) |
| Applicant | RESPIRATORY SUPPORT PRODUCTS, INC. 2552 MCGAW AVE. Irvine, CA 92614 |
| Contact | Anthony V Beran |
| Correspondent | Anthony V Beran RESPIRATORY SUPPORT PRODUCTS, INC. 2552 MCGAW AVE. Irvine, CA 92614 |
| Product Code | BZO |
| CFR Regulation Number | 868.5975 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-13 |
| Decision Date | 1992-06-11 |