OBJECTIVE REFRACTOR— 510(k) K802029

Substantially Equivalent

Zeiss Humphrey System

FDA 510(k) clearance K802029 for OBJECTIVE REFRACTOR, Substantially Equivalent on 1980-11-12. Applicant: Zeiss Humphrey System. Device class: 1.

Clearance details

Applicant: Zeiss Humphrey System
Product code: Code HKO
Device class: Class 1
Regulation: 21 CFR 886.1760
Advisory panel: Ophthalmic
Date received: 1980-08-21
Decision date: 1980-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HKO

K031831 — TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM2003-12-19
K000327 — WAVESCAN WAVEFRONT SYSTEM MODEL HS 12000-05-02
K951179 — DIGITAL RETINOSCOPIC PHOTOMETER1995-05-30
K945959 — VIDEO VISION ANALYZER (VIVA), VRB 1001995-03-01
K942242 — AUTO REF-KERATOMETER, RK-31994-09-02

More clearances from Zeiss Humphrey System

K942439 — ZEISS OPMILAS 144 SURGICAL LASERS1994-07-01
K923211 — DIGITAL OPHTHALMIC ULTRASOUND BIOMICROSCOPE1993-11-08
K923348 — OPHTHALMIC A/B SCAN SYSTEM, MODEL 835 -- MODIFIED1992-12-10
K852639 — HUMPHREY FIELD ANALYZER MODEL 6301985-09-18
K852638 — HUMPHREY IMAGE ANALYZER MODEL 1101985-08-12

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