CO2 GAS WARMER II, MODEL 6-800-00

Insufflator, Laparoscopic

NORTHGATE TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Northgate Technologies, Inc. with the FDA for Co2 Gas Warmer Ii, Model 6-800-00.

Pre-market Notification Details

• Device ID: K992381
• 510k Number: K992381
• Device Name: CO2 GAS WARMER II, MODEL 6-800-00
• Classification: Insufflator, Laparoscopic
• Applicant: NORTHGATE TECHNOLOGIES, INC. 600 CHURCH RD. Elgin, IL 60123
• Contact: Casey Kurek
• Correspondent: Casey Kurek; NORTHGATE TECHNOLOGIES, INC. 600 CHURCH RD. Elgin, IL 60123
• Product Code: HIF
• CFR Regulation Number: 884.1730 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-07-16
• Decision Date: 1999-09-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00817183020240	K992381	000
00817183020233	K992381	000
03596010500601	K992381	000
00817183020592	K992381	000