NOVAMETRIX MODEL 1265 END TIDAL CARBON DIOXIDE MON

Analyzer, Gas, Carbon-dioxide, Gaseous-phase

NOVAMETRIX MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Novametrix Medical Systems, Inc. with the FDA for Novametrix Model 1265 End Tidal Carbon Dioxide Mon.

Pre-market Notification Details

• Device ID: K910019
• 510k Number: K910019
• Device Name: NOVAMETRIX MODEL 1265 END TIDAL CARBON DIOXIDE MON
• Classification: Analyzer, Gas, Carbon-dioxide, Gaseous-phase
• Applicant: NOVAMETRIX MEDICAL SYSTEMS, INC. 1 BARNES INDUSTRIAL PARK RD. P.O. BOX 690 Wallingford, CT 06492
• Contact: Robert Schiffman
• Correspondent: Robert Schiffman; NOVAMETRIX MEDICAL SYSTEMS, INC. 1 BARNES INDUSTRIAL PARK RD. P.O. BOX 690 Wallingford, CT 06492
• Product Code: CCK
• CFR Regulation Number: 868.1400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1991-01-03
• Decision Date: 1991-03-26

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00884838033870	K910019	000
00884838033863	K910019	000
00884838025462	K910019	000
00884838013674	K910019	000