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FDA 510(k)

SHIN NIPPON AUTO REFRACTOMETER QR-007N

K-Number: K901583 · 1990-06-22

ApplicantSoderberg, Inc.
Decision Date1990-06-22
Product CodeHKO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SHIN NIPPON AUTO REFRACTOMETER QR-007N is the device name listed in this FDA 510(k) record. The listed applicant is Soderberg, Inc.. It received FDA 510(k) clearance on 1990-06-22 under 510(k) number K901583. The device is classified under product code HKO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHIN NIPPON AUTO REFRACTOMETER QR-007N?

SHIN NIPPON AUTO REFRACTOMETER QR-007N is a medical device that received FDA 510(k) clearance on 1990-06-22. The listed applicant is Soderberg, Inc.. The 510(k) number is K901583.

When did SHIN NIPPON AUTO REFRACTOMETER QR-007N receive FDA 510(k) clearance?

SHIN NIPPON AUTO REFRACTOMETER QR-007N received FDA 510(k) clearance on 1990-06-22, under 510(k) number K901583.

Who is the listed applicant for SHIN NIPPON AUTO REFRACTOMETER QR-007N?

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

What is the FDA product code for SHIN NIPPON AUTO REFRACTOMETER QR-007N?

The FDA product code for SHIN NIPPON AUTO REFRACTOMETER QR-007N is HKO.

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Related Devices (Code: HKO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K031831TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEMTopcon Medical Systems, Inc.K000327WAVESCAN WAVEFRONT SYSTEM MODEL HS 1Visx, IncorporatedK951179DIGITAL RETINOSCOPIC PHOTOMETERKudi Kalu, Inc.K945959VIDEO VISION ANALYZER (VIVA), VRB 100Tomey Corporation USAK942242AUTO REF-KERATOMETER, RK-3Cannon U.S.A., Inc.K940516AUTO REFF-30Canon, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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