SPIROS

Ventilator, Emergency, Powered (resuscitator)

LIFE SUPPORT PRODUCTS, INC.

The following data is part of a premarket notification filed by Life Support Products, Inc. with the FDA for Spiros.

Pre-market Notification Details

• Device ID: K915564
• 510k Number: K915564
• Device Name: SPIROS
• Classification: Ventilator, Emergency, Powered (resuscitator)
• Applicant: LIFE SUPPORT PRODUCTS, INC. ONE MAUCHLY Irvine, CA 92718
• Contact: Vernon Trimble
• Correspondent: Vernon Trimble; LIFE SUPPORT PRODUCTS, INC. ONE MAUCHLY Irvine, CA 92718
• Product Code: BTL
• CFR Regulation Number: 868.5925 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1991-12-12
• Decision Date: 1992-01-30

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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