BLUE FIELD ENTOPTOSCOPE BFE100— 510(k) K791510

Name: FDA 510(k) clearance K791510
Creator: U.S. Food and Drug Administration
Published: 1979-12-11

Substantially Equivalent

Medical Instrument Research Assoc., Inc.

FDA 510(k) clearance K791510 for BLUE FIELD ENTOPTOSCOPE BFE100, Substantially Equivalent on 1979-12-11. Applicant: Medical Instrument Research Assoc., Inc.. Device class: 2.

Clearance details

Applicant: Medical Instrument Research Assoc., Inc.
Product code: Code HLI
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 1979-08-02
Decision date: 1979-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HLI

view all

K153080 — RTVue XR OCT Avanti with AngioVue Software2016-02-11
K150722 — EnFocus 2300, EnFocus 44002015-12-02
K142953 — OCT-Camera2015-03-04
K141638 — PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE2014-09-17
K133758 — CENTERVUE MACULAR INTEGRITY ASSESSMENT2014-04-23

More clearances from Medical Instrument Research Assoc., Inc.

view all

K780987 — SOFT SILICONE ELASTOMER SPONGE EXPLANT1978-09-28
K770888 — POMERANTZEFF EQUATOR PLUS CAMERA1977-06-03
K760550 — IMPLANT, SILICONE AND TANTALUM1976-10-05

Data sourced from openFDA. This site is unofficial and independent of the FDA.