RESPCARE HYBRID NE FACE MASK, MODEL TBD,; DISPOSABLE, MODEL TBD

Ventilator, Continuous, Facility Use

INNOMED TECHNOLOGIES INC./RESPCARE INC.

The following data is part of a premarket notification filed by Innomed Technologies Inc./respcare Inc. with the FDA for Respcare Hybrid Ne Face Mask, Model Tbd,; Disposable, Model Tbd.

Pre-market Notification Details

• Device ID: K062019
• 510k Number: K062019
• Device Name: RESPCARE HYBRID NE FACE MASK, MODEL TBD,; DISPOSABLE, MODEL TBD
• Classification: Ventilator, Continuous, Facility Use
• Applicant: INNOMED TECHNOLOGIES INC./RESPCARE INC. 6601 LYONS ROAD SUITES B1-B4 Coconut Creek, FL 33073
• Contact: Frank Pelc
• Correspondent: Frank Pelc; INNOMED TECHNOLOGIES INC./RESPCARE INC. 6601 LYONS ROAD SUITES B1-B4 Coconut Creek, FL 33073
• Product Code: CBK
• CFR Regulation Number: 868.5895 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-07-17
• Decision Date: 2006-08-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10607411945738	K062019	000
10607411943789	K062019	000
10607411943796	K062019	000
10607411943802	K062019	000
10607411943819	K062019	000
10607411943826	K062019	000
10607411945622	K062019	000
10607411945639	K062019	000
10607411945646	K062019	000
10607411945653	K062019	000
10607411945660	K062019	000
10607411945677	K062019	000
10607411945714	K062019	000
10607411945721	K062019	000
10607411943772	K062019	000