CALEO

Incubator, Neonatal

DRAGER MEDIZINTECHNIK GMBH

The following data is part of a premarket notification filed by Drager Medizintechnik Gmbh with the FDA for Caleo.

Pre-market Notification Details

• Device ID: K003067
• 510k Number: K003067
• Device Name: CALEO
• Classification: Incubator, Neonatal
• Applicant: DRAGER MEDIZINTECHNIK GMBH 3136 QUARRY RD. Telford, PA 18969
• Contact: Jim Brennan
• Correspondent: Jim Brennan; DRAGER MEDIZINTECHNIK GMBH 3136 QUARRY RD. Telford, PA 18969
• Product Code: FMZ
• CFR Regulation Number: 880.5400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-10-02
• Decision Date: 2000-12-13

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04048675240341	K003067	000