The following data is part of a premarket notification filed by Minesafety Appliances Co. with the FDA for Minicap Tm 100 Capnometer.
Device ID | K883090 |
510k Number | K883090 |
Device Name: | MINICAP TM 100 CAPNOMETER |
Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
Applicant | MINESAFETY APPLIANCES CO. P.O. BOX 427CRABERRY TWP Pittsburgh, PA 15230 |
Contact | Thomas P Mcclory |
Correspondent | Thomas P Mcclory MINESAFETY APPLIANCES CO. P.O. BOX 427CRABERRY TWP Pittsburgh, PA 15230 |
Product Code | CCK |
CFR Regulation Number | 868.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-07-22 |
Decision Date | 1989-01-30 |