UTOPIA

Ventilator, Non-continuous (respirator)

RESPCARE INC.

The following data is part of a premarket notification filed by Respcare Inc. with the FDA for Utopia.

Pre-market Notification Details

• Device ID: K052249
• 510k Number: K052249
• Device Name: UTOPIA
• Classification: Ventilator, Non-continuous (respirator)
• Applicant: RESPCARE INC. 6601 LYONS ROAD, SUITES B1-B4 Coconut Creek, FL 33073
• Contact: Frank Pelc
• Correspondent: Frank Pelc; RESPCARE INC. 6601 LYONS ROAD, SUITES B1-B4 Coconut Creek, FL 33073
• Product Code: BZD
• CFR Regulation Number: 868.5905 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-08-18
• Decision Date: 2005-12-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10607411945707	K052249	000
10607411945691	K052249	000
10607411945684	K052249	000
10607411945615	K052249	000
10607411945608	K052249	000
00607411945595	K052249	000