ALPHA MX (20)/ULTRA PC (30)

Gas-machine, Anesthesia

TECHNICAL MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Technical Medical Products, Inc. with the FDA for Alpha Mx (20)/ultra Pc (30).

Pre-market Notification Details

• Device ID: K970163
• 510k Number: K970163
• Device Name: ALPHA MX (20)/ULTRA PC (30)
• Classification: Gas-machine, Anesthesia
• Applicant: TECHNICAL MEDICAL PRODUCTS, INC. 2020 WEST MELINDA LN. Phoenix, AZ 85027
• Contact: Jim R Moore
• Correspondent: Jim R Moore; TECHNICAL MEDICAL PRODUCTS, INC. 2020 WEST MELINDA LN. Phoenix, AZ 85027
• Product Code: BSZ
• CFR Regulation Number: 868.5160 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-01-16
• Decision Date: 1997-12-10

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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