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FDA 510(k)

PNEUMATIC VITRECTOMY CONTROL UNIT

K-Number: K781471 · 1978-11-08

ApplicantHelfgott Medical Instruments
Decision Date1978-11-08
Product CodeHQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PNEUMATIC VITRECTOMY CONTROL UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Helfgott Medical Instruments. It received FDA 510(k) clearance on 1978-11-08 under 510(k) number K781471. The device is classified under product code HQE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PNEUMATIC VITRECTOMY CONTROL UNIT?

PNEUMATIC VITRECTOMY CONTROL UNIT is a medical device that received FDA 510(k) clearance on 1978-11-08. The listed applicant is Helfgott Medical Instruments. The 510(k) number is K781471.

When did PNEUMATIC VITRECTOMY CONTROL UNIT receive FDA 510(k) clearance?

PNEUMATIC VITRECTOMY CONTROL UNIT received FDA 510(k) clearance on 1978-11-08, under 510(k) number K781471.

Who is the listed applicant for PNEUMATIC VITRECTOMY CONTROL UNIT?

The FDA 510(k) record lists Helfgott Medical Instruments as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PNEUMATIC VITRECTOMY CONTROL UNIT?

The FDA product code for PNEUMATIC VITRECTOMY CONTROL UNIT is HQE.

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Related Devices (Code: HQE)

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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Official Source

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

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