Decision Date1990-01-22
Product CodeBZE
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
PROTOLOGIC MODEL SER-1 is the device name listed in this FDA 510(k) record. The listed applicant is Protologic, Inc.. It received FDA 510(k) clearance on 1990-01-22 under 510(k) number K894936. The device is classified under product code BZE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PROTOLOGIC MODEL SER-1?
PROTOLOGIC MODEL SER-1 is a medical device that received FDA 510(k) clearance on 1990-01-22. The listed applicant is Protologic, Inc.. The 510(k) number is K894936.
When did PROTOLOGIC MODEL SER-1 receive FDA 510(k) clearance?
PROTOLOGIC MODEL SER-1 received FDA 510(k) clearance on 1990-01-22, under 510(k) number K894936.
Who is the listed applicant for PROTOLOGIC MODEL SER-1?
The FDA 510(k) record lists Protologic, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PROTOLOGIC MODEL SER-1?
The FDA product code for PROTOLOGIC MODEL SER-1 is BZE.
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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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