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FDA 510(k)

AUTO REFRACTOMETER NR-1000

K-Number: K802958 · 1981-04-23

ApplicantNippon Kogaku, Inc.
Decision Date1981-04-23
Product CodeHKO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

AUTO REFRACTOMETER NR-1000 is the device name listed in this FDA 510(k) record. The listed applicant is Nippon Kogaku, Inc.. It received FDA 510(k) clearance on 1981-04-23 under 510(k) number K802958. 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 AUTO REFRACTOMETER NR-1000?

AUTO REFRACTOMETER NR-1000 is a medical device that received FDA 510(k) clearance on 1981-04-23. The listed applicant is Nippon Kogaku, Inc.. The 510(k) number is K802958.

When did AUTO REFRACTOMETER NR-1000 receive FDA 510(k) clearance?

AUTO REFRACTOMETER NR-1000 received FDA 510(k) clearance on 1981-04-23, under 510(k) number K802958.

Who is the listed applicant for AUTO REFRACTOMETER NR-1000?

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

What is the FDA product code for AUTO REFRACTOMETER NR-1000?

The FDA product code for AUTO REFRACTOMETER NR-1000 is HKO.

Related Clinical Trials

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.

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Other records listing Nippon Kogaku, Inc. as applicant

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.

K802959NIKON URINE REFRACTOMER SG-1

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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