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FDA 510(k)

FEMTEST

K-Number: K844173 · 1985-08-14

ApplicantBionexus, Inc.
Decision Date1985-08-14
Product CodeHES
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FEMTEST is the device name listed in this FDA 510(k) record. The listed applicant is Bionexus, Inc.. It received FDA 510(k) clearance on 1985-08-14 under 510(k) number K844173. The device is classified under product code HES. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FEMTEST?

FEMTEST is a medical device that received FDA 510(k) clearance on 1985-08-14. The listed applicant is Bionexus, Inc.. The 510(k) number is K844173.

When did FEMTEST receive FDA 510(k) clearance?

FEMTEST received FDA 510(k) clearance on 1985-08-14, under 510(k) number K844173.

Who is the listed applicant for FEMTEST?

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

What is the FDA product code for FEMTEST?

The FDA product code for FEMTEST is HES.

Related Clinical Trials

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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Other records listing Bionexus, 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.

K870209NEXADENT (DENTAL CEMENT)

Related Devices (Code: HES)

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.

K000340HYSTALOG HSG CATHETERRocket Medical PlcK903209MAXI-FLOW INSUFFLATOR TUBING SET W/FILTERAdler Instrument Co.K903208MAXI-FLOW INSUFFLATOR TUBING SETAdler Instrument Co.K904473KRONNER MANIPUJECTORUnimar, Inc.K901413CORE DISPOSABLE INSUFFLATION TUBINGCore Dynamics, Inc.K891290SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETERCook Ob/Gyn

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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