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FDA 510(k)

SCANHEADS-ACCESS 10PV, BIOSTATIC

K-Number: K843620 · 1985-03-12

ApplicantAdvanced Technology Laboratories, Inc.
Decision Date1985-03-12
Product CodeJOP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SCANHEADS-ACCESS 10PV, BIOSTATIC is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Technology Laboratories, Inc.. It received FDA 510(k) clearance on 1985-03-12 under 510(k) number K843620. The device is classified under product code JOP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCANHEADS-ACCESS 10PV, BIOSTATIC?

SCANHEADS-ACCESS 10PV, BIOSTATIC is a medical device that received FDA 510(k) clearance on 1985-03-12. The listed applicant is Advanced Technology Laboratories, Inc.. The 510(k) number is K843620.

When did SCANHEADS-ACCESS 10PV, BIOSTATIC receive FDA 510(k) clearance?

SCANHEADS-ACCESS 10PV, BIOSTATIC received FDA 510(k) clearance on 1985-03-12, under 510(k) number K843620.

Who is the listed applicant for SCANHEADS-ACCESS 10PV, BIOSTATIC?

The FDA 510(k) record lists Advanced Technology Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SCANHEADS-ACCESS 10PV, BIOSTATIC?

The FDA product code for SCANHEADS-ACCESS 10PV, BIOSTATIC is JOP.

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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.

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