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510(k) K791510

BLUE FIELD ENTOPTOSCOPE BFE100 by Medical Instrument Research Assoc., Inc. — Product Code HLI

K791510 is an FDA 510(k) premarket notification submitted by Medical Instrument Research Assoc., Inc. for the device "BLUE FIELD ENTOPTOSCOPE BFE100". The FDA issued a decision of Substantially Equivalent on December 11, 1979. The device falls under product code HLI (Ophthalmoscope, Ac-Powered), a Class II device regulated under 21 CFR 886.1570. Medical Instrument Research Assoc., Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1979
Date Received
August 2, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ophthalmoscope, Ac-Powered
Device Class
Class II
Regulation Number
886.1570
Review Panel
OP
Submission Type

Other clearances by Medical Instrument Research Assoc., Inc.

  • K780987 — SOFT SILICONE ELASTOMER SPONGE EXPLANT (September 28, 1978)
  • K770888 — POMERANTZEFF EQUATOR PLUS CAMERA (June 3, 1977)
  • K760550 — IMPLANT, SILICONE AND TANTALUM (October 5, 1976)

Other clearances for product code HLI

  • K153080 — RTVue XR OCT Avanti with AngioVue Software (February 11, 2016)
  • K150722 — EnFocus 2300, EnFocus 4400 (December 2, 2015)
  • K142953 — OCT-Camera (March 4, 2015)
  • K141638 — PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE (September 17, 2014)
  • K133758 — CENTERVUE MACULAR INTEGRITY ASSESSMENT (April 23, 2014)
  • K131939 — AMICO DH-W35 OPHTHALMOSCOPE SERIES (March 26, 2014)
  • K133892 — IVUE 500 (March 19, 2014)
  • K123316 — HEINE OMEGA 500 (February 26, 2013)
  • K121739 — IVUE WITH NORMATIVE DATABASE (January 18, 2013)
  • K120057 — ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS) (May 11, 2012)

FDA data resources