The following data is part of a premarket notification filed by Respiratory Support Products, Inc. with the FDA for Modified Gas Sampling Kit.
| Device ID | K863640 |
| 510k Number | K863640 |
| Device Name: | MODIFIED GAS SAMPLING KIT |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | RESPIRATORY SUPPORT PRODUCTS, INC. 3183-D AIRWAY AVE. Costa Mesa, CA 92626 |
| Contact | Anthony V Beran |
| Correspondent | Anthony V Beran RESPIRATORY SUPPORT PRODUCTS, INC. 3183-D AIRWAY AVE. Costa Mesa, CA 92626 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-03 |
| Decision Date | 1986-10-08 |