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FDA 510(k)

GEL-SCAN DIAGNOSTIC ULTRASOUND COUPLING

K-Number: K834088 · 1983-12-15

ApplicantWhs Products, Inc.
Decision Date1983-12-15
Product CodeHEM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

GEL-SCAN DIAGNOSTIC ULTRASOUND COUPLING is the device name listed in this FDA 510(k) record. The listed applicant is Whs Products, Inc.. It received FDA 510(k) clearance on 1983-12-15 under 510(k) number K834088. The device is classified under product code HEM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEL-SCAN DIAGNOSTIC ULTRASOUND COUPLING?

GEL-SCAN DIAGNOSTIC ULTRASOUND COUPLING is a medical device that received FDA 510(k) clearance on 1983-12-15. The listed applicant is Whs Products, Inc.. The 510(k) number is K834088.

When did GEL-SCAN DIAGNOSTIC ULTRASOUND COUPLING receive FDA 510(k) clearance?

GEL-SCAN DIAGNOSTIC ULTRASOUND COUPLING received FDA 510(k) clearance on 1983-12-15, under 510(k) number K834088.

Who is the listed applicant for GEL-SCAN DIAGNOSTIC ULTRASOUND COUPLING?

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

What is the FDA product code for GEL-SCAN DIAGNOSTIC ULTRASOUND COUPLING?

The FDA product code for GEL-SCAN DIAGNOSTIC ULTRASOUND COUPLING is HEM.

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 Whs Products, 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.

K833172ECG-GEL ELECTRODE GELK828673RICH-MAR ULTRASOUND COUPLING LOTIONK827885BIO-DERM COUPLING LOTION

Related Devices (Code: HEM)

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.

K951393ABACUS OB ULTRASOUNG COMPUTER SOFTWARESolomon Technology LabsK942490BABE COMPUTER POGRAM FOR OBSTETRIC ULTRASOUNDMedical Soft, Inc.K910426SDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENTShimadzu Medical SystemsK905000ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCERCorometrics Medical Systems, Inc.K900505SONOACE 88 PORTABLE ULTRASOUND SCANNERMedison Co., Ltd.K900271MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINKDigisonics, 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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