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510(k) K901583

SHIN NIPPON AUTO REFRACTOMETER QR-007N by Soderberg, Inc. — Product Code HKO

K901583 is an FDA 510(k) premarket notification submitted by Soderberg, Inc. for the device "SHIN NIPPON AUTO REFRACTOMETER QR-007N". The FDA issued a decision of Substantially Equivalent on June 22, 1990. The device falls under product code HKO (Refractometer, Ophthalmic), a Class I device regulated under 21 CFR 886.1760.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1990
Date Received
April 4, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Refractometer, Ophthalmic
Device Class
Class I
Regulation Number
886.1760
Review Panel
OP
Submission Type

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  • K951179 — DIGITAL RETINOSCOPIC PHOTOMETER (May 30, 1995)
  • K945959 — VIDEO VISION ANALYZER (VIVA), VRB 100 (March 1, 1995)
  • K942242 — AUTO REF-KERATOMETER, RK-3 (September 2, 1994)
  • K940516 — AUTO REFF-30 (July 12, 1994)
  • K925304 — AUTOREF LENSMETER RL-10 (February 17, 1994)
  • K924741 — OPTEC 3000 (April 6, 1993)
  • K924790 — BURTON AUTO REFRACTOR - MODEL BAR-7 (April 5, 1993)
  • K924778 — BURTON AUTO REFRACTOR/KERATOMETER - MODEL BARK-8 (April 5, 1993)

FDA data resources