PEDI-CAP

Analyzer, Gas, Carbon-dioxide, Gaseous-phase

NELLCOR, INC.

The following data is part of a premarket notification filed by Nellcor, Inc. with the FDA for Pedi-cap.

Pre-market Notification Details

• Device ID: K944400
• 510k Number: K944400
• Device Name: PEDI-CAP
• Classification: Analyzer, Gas, Carbon-dioxide, Gaseous-phase
• Applicant: NELLCOR, INC. 4280 HACIENDA DR. P.O. BOX 8004 Pleasanton, CA 94588
• Contact: Marsha J Stone
• Correspondent: Marsha J Stone; NELLCOR, INC. 4280 HACIENDA DR. P.O. BOX 8004 Pleasanton, CA 94588
• Product Code: CCK
• CFR Regulation Number: 868.1400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-09-08
• Decision Date: 1994-09-27

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10884521112865	K944400	000
10884521083912	K944400	000