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FDA 510(k)

SONICOMP

K-Number: K833488 · 1983-11-28

ApplicantSonicaid, Inc.
Decision Date1983-11-28
Product CodeHEM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SONICOMP is the device name listed in this FDA 510(k) record. The listed applicant is Sonicaid, Inc.. It received FDA 510(k) clearance on 1983-11-28 under 510(k) number K833488. 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 SONICOMP?

SONICOMP is a medical device that received FDA 510(k) clearance on 1983-11-28. The listed applicant is Sonicaid, Inc.. The 510(k) number is K833488.

When did SONICOMP receive FDA 510(k) clearance?

SONICOMP received FDA 510(k) clearance on 1983-11-28, under 510(k) number K833488.

Who is the listed applicant for SONICOMP?

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

What is the FDA product code for SONICOMP?

The FDA product code for SONICOMP is HEM.

Related Clinical Trials

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Other records listing Sonicaid, 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.

K873673BV105 (&BV105R) VASCULAR FLOW DETECTOR W/OPTIONALK8720745 MHZ TRANSDUCERK863803VASOPULSE(TM)/MODEL 5000K862720VASOFLO-3 & EXTRAVASCULAR BLOOD FLOW PROBESK861237VASOVIEW DUPLEX IMAGING SYSTEMK851102VASOSCREEN IMPEDANCE PLETHYSMOGRAPH

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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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