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FDA 510(k)

HYSTERO CO2-PNEU 2221

K-Number: K964136 · 1997-01-10

ApplicantRichard Wolf Medical Instruments Corp.
Decision Date1997-01-10
Product CodeHIG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

HYSTERO CO2-PNEU 2221 is the device name listed in this FDA 510(k) record. The listed applicant is Richard Wolf Medical Instruments Corp.. It received FDA 510(k) clearance on 1997-01-10 under 510(k) number K964136. The device is classified under product code HIG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYSTERO CO2-PNEU 2221?

HYSTERO CO2-PNEU 2221 is a medical device that received FDA 510(k) clearance on 1997-01-10. The listed applicant is Richard Wolf Medical Instruments Corp.. The 510(k) number is K964136.

When did HYSTERO CO2-PNEU 2221 receive FDA 510(k) clearance?

HYSTERO CO2-PNEU 2221 received FDA 510(k) clearance on 1997-01-10, under 510(k) number K964136.

Who is the listed applicant for HYSTERO CO2-PNEU 2221?

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

What is the FDA product code for HYSTERO CO2-PNEU 2221?

The FDA product code for HYSTERO CO2-PNEU 2221 is HIG.

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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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