DATUM

Vaporizer, Anesthesia, Non-heated

BLEASE USA, INC.

The following data is part of a premarket notification filed by Blease Usa, Inc. with the FDA for Datum.

Pre-market Notification Details

• Device ID: K942799
• 510k Number: K942799
• Device Name: DATUM
• Classification: Vaporizer, Anesthesia, Non-heated
• Applicant: BLEASE USA, INC. P.O. BOX 1395 Lynnwood, WA 98036
• Contact: Richard Kirschner
• Correspondent: Richard Kirschner; BLEASE USA, INC. P.O. BOX 1395 Lynnwood, WA 98036
• Product Code: CAD
• CFR Regulation Number: 868.5880 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-06-15
• Decision Date: 1995-04-13

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10841522118234	K942799	000
10841522118227	K942799	000
10841522118241	K942799	000
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10841522119347	K942799	000