The following data is part of a premarket notification filed by Nordan Smith Welding Supplies with the FDA for Clinical Blood Gas Mixture.
Device ID | K942866 |
510k Number | K942866 |
Device Name: | CLINICAL BLOOD GAS MIXTURE |
Classification | Gas, Calibration (specified Concentration) |
Applicant | NORDAN SMITH WELDING SUPPLIES 5051 HIGHWAY 42 P.O. BOX 107 Hattiesburg, MS 39403 |
Contact | William Dowden |
Correspondent | William Dowden NORDAN SMITH WELDING SUPPLIES 5051 HIGHWAY 42 P.O. BOX 107 Hattiesburg, MS 39403 |
Product Code | BXK |
CFR Regulation Number | 868.6400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-06-17 |
Decision Date | 1994-09-01 |