Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

605 VACU-MAX

K-Number: K941961 · 1995-03-02

Decision Date1995-03-02
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

605 VACU-MAX is the device name listed in this FDA 510(k) record. The listed applicant is Medical Industries America, Inc.. It received FDA 510(k) clearance on 1995-03-02 under 510(k) number K941961. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 605 VACU-MAX?

605 VACU-MAX is a medical device that received FDA 510(k) clearance on 1995-03-02. The listed applicant is Medical Industries America, Inc.. The 510(k) number is K941961.

When did 605 VACU-MAX receive FDA 510(k) clearance?

605 VACU-MAX received FDA 510(k) clearance on 1995-03-02, under 510(k) number K941961.

Who is the listed applicant for 605 VACU-MAX?

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

What is the FDA product code for 605 VACU-MAX?

The FDA product code for 605 VACU-MAX is BTA.

Other records listing Medical Industries America, Inc. as applicant

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.

View all 19 devices →

Related Devices (Code: BTA)

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.

Official Source

View on FDA Database →

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

↑