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FDA 510(k)

BIOVISION ENDOCULAR PROBE

K-Number: K905115 · 1991-02-11

ApplicantDouglas James Donaldson Compliance Services
Decision Date1991-02-11
Product CodeHGF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

BIOVISION ENDOCULAR PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Douglas James Donaldson Compliance Services. It received FDA 510(k) clearance on 1991-02-11 under 510(k) number K905115. The device is classified under product code HGF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOVISION ENDOCULAR PROBE?

BIOVISION ENDOCULAR PROBE is a medical device that received FDA 510(k) clearance on 1991-02-11. The listed applicant is Douglas James Donaldson Compliance Services. The 510(k) number is K905115.

When did BIOVISION ENDOCULAR PROBE receive FDA 510(k) clearance?

BIOVISION ENDOCULAR PROBE received FDA 510(k) clearance on 1991-02-11, under 510(k) number K905115.

Who is the listed applicant for BIOVISION ENDOCULAR PROBE?

The FDA 510(k) record lists Douglas James Donaldson Compliance Services as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOVISION ENDOCULAR PROBE?

The FDA product code for BIOVISION ENDOCULAR PROBE is HGF.

Related Clinical Trials

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Other records listing Douglas James Donaldson Compliance Services 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.

K912987CRYSTAL FOCUS EMER LASER PHOTO VIS RED OPER MODEK912284BIOVISION ENDOCULAR PROBE ACCESS DELIV SYST, MODIFK905453CRYSTAL FOCUS EMERALD LASER/SLT OPHF 0.6 ENDO HANDK904366CRYSTAL FOCUS EMERALD-CW LASER PHOTOCOAGULATOR

Related Devices (Code: HGF)

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.

K945179BOTTLE COLLECTION SETMedgyn Products, Inc.K904248MODEL GLASE 210 HOLMIUM LASER SYSTEMCharles L. Rose and Co., Inc.K890787O-020 LASER INDIRECT OPHTHALMOSCOPEHgm Medical Laser Systems, 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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