SPEACELABS MULTIGAS MODULE

Analyzer, Gas, Nitrous-oxide, Gaseous Phase (anesthetic Conc.)

SPACELABS HEALTHCARE

The following data is part of a premarket notification filed by Spacelabs Healthcare with the FDA for Speacelabs Multigas Module.

Pre-market Notification Details

• Device ID: K112173
• 510k Number: K112173
• Device Name: SPEACELABS MULTIGAS MODULE
• Classification: Analyzer, Gas, Nitrous-oxide, Gaseous Phase (anesthetic Conc.)
• Applicant: SPACELABS HEALTHCARE P.O. BOX 3018 Nederland, CO 80466
• Contact: Thomas Kroenke
• Correspondent: Thomas Kroenke; SPACELABS HEALTHCARE P.O. BOX 3018 Nederland, CO 80466
• Product Code: CBR
• Subsequent Product Code: CBQ
• Subsequent Product Code: CBS
• Subsequent Product Code: CCK
• Subsequent Product Code: CCL
• Subsequent Product Code: NHO
• Subsequent Product Code: NHP
• Subsequent Product Code: NHQ
• CFR Regulation Number: 868.1700 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-07-28
• Decision Date: 2011-10-05
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10841522127359	K112173	000
10841522127342	K112173	000
10841522113109	K112173	000
00841522127369	K112173	000
10841522108846	K112173	000
00841522127376	K112173	000