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FDA 510(k)

BLUE FIELD ENTOPTOSCOPE BFE100

K-Number: K791510 · 1979-12-11

ApplicantMedical Instrument Research Assoc., Inc.
Decision Date1979-12-11
Product CodeHLI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

BLUE FIELD ENTOPTOSCOPE BFE100 is the device name listed in this FDA 510(k) record. The listed applicant is Medical Instrument Research Assoc., Inc.. It received FDA 510(k) clearance on 1979-12-11 under 510(k) number K791510. The device is classified under product code HLI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLUE FIELD ENTOPTOSCOPE BFE100?

BLUE FIELD ENTOPTOSCOPE BFE100 is a medical device that received FDA 510(k) clearance on 1979-12-11. The listed applicant is Medical Instrument Research Assoc., Inc.. The 510(k) number is K791510.

When did BLUE FIELD ENTOPTOSCOPE BFE100 receive FDA 510(k) clearance?

BLUE FIELD ENTOPTOSCOPE BFE100 received FDA 510(k) clearance on 1979-12-11, under 510(k) number K791510.

Who is the listed applicant for BLUE FIELD ENTOPTOSCOPE BFE100?

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

What is the FDA product code for BLUE FIELD ENTOPTOSCOPE BFE100?

The FDA product code for BLUE FIELD ENTOPTOSCOPE BFE100 is HLI.

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Official Source

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