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FDA 510(k)

BURTON AUTO REFRACTOR/KERATOMETER - MODEL BARK-8

K-Number: K924778 · 1993-04-05

ApplicantR.H. Burton Co.
Decision Date1993-04-05
Product CodeHKO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

BURTON AUTO REFRACTOR/KERATOMETER - MODEL BARK-8 is the device name listed in this FDA 510(k) record. The listed applicant is R.H. Burton Co.. It received FDA 510(k) clearance on 1993-04-05 under 510(k) number K924778. 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 BURTON AUTO REFRACTOR/KERATOMETER - MODEL BARK-8?

BURTON AUTO REFRACTOR/KERATOMETER - MODEL BARK-8 is a medical device that received FDA 510(k) clearance on 1993-04-05. The listed applicant is R.H. Burton Co.. The 510(k) number is K924778.

When did BURTON AUTO REFRACTOR/KERATOMETER - MODEL BARK-8 receive FDA 510(k) clearance?

BURTON AUTO REFRACTOR/KERATOMETER - MODEL BARK-8 received FDA 510(k) clearance on 1993-04-05, under 510(k) number K924778.

Who is the listed applicant for BURTON AUTO REFRACTOR/KERATOMETER - MODEL BARK-8?

The FDA 510(k) record lists R.H. Burton Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BURTON AUTO REFRACTOR/KERATOMETER - MODEL BARK-8?

The FDA product code for BURTON AUTO REFRACTOR/KERATOMETER - MODEL BARK-8 is HKO.

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Other records listing R.H. Burton Co. 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.

K924773BURTON H- BASE TABLE - MODEL 1990K924774BURTON AUTOMATIC PROJECTOR - MODEL CP-40K924786BURTON TRIAL LENS SETK924783BURTON SLIT LAMP - MODEL 850K924777BURTON APPLANATION TONOMETER - MODEL T850 & T1000K924784BURTON PROJECTOR HEAD - MODEL 6000-H

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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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