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FDA 510(k)

ALPHA MX (20)/ULTRA PC (30)

K-Number: K970163 · 1997-12-10

ApplicantTechnical Medical Products, Inc.
Decision Date1997-12-10
Product CodeBSZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ALPHA MX (20)/ULTRA PC (30) is the device name listed in this FDA 510(k) record. The listed applicant is Technical Medical Products, Inc.. It received FDA 510(k) clearance on 1997-12-10 under 510(k) number K970163. The device is classified under product code BSZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALPHA MX (20)/ULTRA PC (30)?

ALPHA MX (20)/ULTRA PC (30) is a medical device that received FDA 510(k) clearance on 1997-12-10. The listed applicant is Technical Medical Products, Inc.. The 510(k) number is K970163.

When did ALPHA MX (20)/ULTRA PC (30) receive FDA 510(k) clearance?

ALPHA MX (20)/ULTRA PC (30) received FDA 510(k) clearance on 1997-12-10, under 510(k) number K970163.

Who is the listed applicant for ALPHA MX (20)/ULTRA PC (30)?

The FDA 510(k) record lists Technical Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALPHA MX (20)/ULTRA PC (30)?

The FDA product code for ALPHA MX (20)/ULTRA PC (30) is BSZ.

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Other records listing Technical Medical Products, Inc. as applicant

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Related Devices (Code: BSZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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