RESUSCITATOR

Ventilator, Emergency, Manual (resuscitator)

AMERICAN MEDICAL TECHNOLOGY, INC.

The following data is part of a premarket notification filed by American Medical Technology, Inc. with the FDA for Resuscitator.

Pre-market Notification Details

• Device ID: K874567
• 510k Number: K874567
• Device Name: RESUSCITATOR
• Classification: Ventilator, Emergency, Manual (resuscitator)
• Applicant: AMERICAN MEDICAL TECHNOLOGY, INC. C/O VENTURE MGMT CONSULTING BOX 160 GRAND VIEW TERRACE EXT Brooklyn, CT 06234
• Contact: Gene Zamba
• Correspondent: Gene Zamba; AMERICAN MEDICAL TECHNOLOGY, INC. C/O VENTURE MGMT CONSULTING BOX 160 GRAND VIEW TERRACE EXT Brooklyn, CT 06234
• Product Code: BTM
• CFR Regulation Number: 868.5915 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1987-11-05
• Decision Date: 1988-02-29