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FDA 510(k)

UNOMETER 500

K-Number: K896732 · 1990-11-02

ApplicantUnoplast A/S
Decision Date1990-11-02
Product CodeEXR
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UNOMETER 500 is the device name listed in this FDA 510(k) record. The listed applicant is Unoplast A/S. It received FDA 510(k) clearance on 1990-11-02 under 510(k) number K896732. The device is classified under product code EXR. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNOMETER 500?

UNOMETER 500 is a medical device that received FDA 510(k) clearance on 1990-11-02. The listed applicant is Unoplast A/S. The 510(k) number is K896732.

When did UNOMETER 500 receive FDA 510(k) clearance?

UNOMETER 500 received FDA 510(k) clearance on 1990-11-02, under 510(k) number K896732.

Who is the listed applicant for UNOMETER 500?

The FDA 510(k) record lists Unoplast A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNOMETER 500?

The FDA product code for UNOMETER 500 is EXR.

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 Unoplast A/S 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.

K896734FEEDING TUBEK896729NELATON-, FEMALE - OR TIEMANN CATHETERK896730SUCTION CATHETER STRAIGHT/COUDEK896731OXYGEN CATHETERSK896733VACCONK802248DISARP ORIGINAL

View all 7 devices →

Related Devices (Code: EXR)

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.

K934142URINARY DRAINAGE BAGKey Medical Services, Inc.K935578URINE METERPuritas Health Care, Inc.K911258KENDALL PEDIATRIC URINE METERKendall Healthcare Products Co. Div.Of Tyco HealthK870240COMPRESS AND SKULLCAP, HEAD DRESSINGFraass Survival Systems, Inc.K771561DOVER URINE METERWill Ross Co.K770939URINE TESTER, MODEL 701Brother Scientific Products, 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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