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FDA 510(k)

OCU-1

K-Number: K875030 · 1988-05-03

ApplicantRudolph Beaver, Inc.
Decision Date1988-05-03
Product CodeHMX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OCU-1 is the device name listed in this FDA 510(k) record. The listed applicant is Rudolph Beaver, Inc.. It received FDA 510(k) clearance on 1988-05-03 under 510(k) number K875030. The device is classified under product code HMX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OCU-1?

OCU-1 is a medical device that received FDA 510(k) clearance on 1988-05-03. The listed applicant is Rudolph Beaver, Inc.. The 510(k) number is K875030.

When did OCU-1 receive FDA 510(k) clearance?

OCU-1 received FDA 510(k) clearance on 1988-05-03, under 510(k) number K875030.

Who is the listed applicant for OCU-1?

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

What is the FDA product code for OCU-1?

The FDA product code for OCU-1 is HMX.

Other records listing Rudolph Beaver, 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.

K883361ARTHRO-TRAC(TM)K862709MECHANICAL CYSTITOMEK860305BEAVER MICRO-GEM GAUGE BLOCKK852828BEAVER R-K KNIFEK853129BEAVER MULTIPURPOSE SAPPHIRE KNIFE

Related Devices (Code: HMX)

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.

K010305WEISS RETINAL CANNULAMicron Surgical, Inc.K000457VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIESRetinalabs.ComK970873ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)American Medical Devices, Inc.K943932STERISEAL OPHTHALMIC CANNULAPharma-Plast, Ltd.K942403INFUSION CANNULAMicrosurgical Technology, Inc.K934844INTER TIP TMicrosurgical Technology, 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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