The following data is part of a premarket notification filed by Vulcan Laboratories, Inc. with the FDA for Stat Gas Module.
| Device ID | K851451 |
| 510k Number | K851451 |
| Device Name: | STAT GAS MODULE |
| Classification | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia |
| Applicant | VULCAN LABORATORIES, INC. 8038 RUGBY AVE. Birmingham, AL 35206 |
| Contact | Joe Emrico |
| Correspondent | Joe Emrico VULCAN LABORATORIES, INC. 8038 RUGBY AVE. Birmingham, AL 35206 |
| Product Code | KLK |
| CFR Regulation Number | 868.2500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-11 |
| Decision Date | 1985-08-02 |