The following data is part of a premarket notification filed by Vital Signs, Inc. with the FDA for Gas Sampling Interfaces.
Device ID | K914337 |
510k Number | K914337 |
Device Name: | GAS SAMPLING INTERFACES |
Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
Applicant | VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512 |
Contact | Patricia M Kynes |
Correspondent | Patricia M Kynes VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512 |
Product Code | CCK |
CFR Regulation Number | 868.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-09-27 |
Decision Date | 1992-03-11 |