MIN-FILTER/S, UNI-FILTER JUNIOR, UNI-FILTER/S ANGLED AND UNI-FILTER

Filter, Bacterial, Breathing-circuit

DATEX-OHMEDA, INC.

The following data is part of a premarket notification filed by Datex-ohmeda, Inc. with the FDA for Min-filter/s, Uni-filter Junior, Uni-filter/s Angled And Uni-filter.

Pre-market Notification Details

• Device ID: K043120
• 510k Number: K043120
• Device Name: MIN-FILTER/S, UNI-FILTER JUNIOR, UNI-FILTER/S ANGLED AND UNI-FILTER
• Classification: Filter, Bacterial, Breathing-circuit
• Applicant: DATEX-OHMEDA, INC. 86 PILGRIM RD. Needham, MA 02492
• Contact: Joel Kent
• Correspondent: Joel Kent; DATEX-OHMEDA, INC. 86 PILGRIM RD. Needham, MA 02492
• Product Code: CAH
• CFR Regulation Number: 868.5260 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-11-12
• Decision Date: 2005-03-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20889483601508	K043120	000
10889483586563	K043120	000
20889483590598	K043120	000
20889483601584	K043120	000
20889483602574	K043120	000
20889483603120	K043120	000
20889483603137	K043120	000
20889483603151	K043120	000
20889483601492	K043120	000
10889483586556	K043120	000