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FDA 510(k)

FETA SCAN 1000 OBSTETRICAL IMAGER

K-Number: K852439 · 1985-08-30

ApplicantInternational Biomedics, Inc.
Decision Date1985-08-30
Product CodeHEM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FETA SCAN 1000 OBSTETRICAL IMAGER is the device name listed in this FDA 510(k) record. The listed applicant is International Biomedics, Inc.. It received FDA 510(k) clearance on 1985-08-30 under 510(k) number K852439. 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 FETA SCAN 1000 OBSTETRICAL IMAGER?

FETA SCAN 1000 OBSTETRICAL IMAGER is a medical device that received FDA 510(k) clearance on 1985-08-30. The listed applicant is International Biomedics, Inc.. The 510(k) number is K852439.

When did FETA SCAN 1000 OBSTETRICAL IMAGER receive FDA 510(k) clearance?

FETA SCAN 1000 OBSTETRICAL IMAGER received FDA 510(k) clearance on 1985-08-30, under 510(k) number K852439.

Who is the listed applicant for FETA SCAN 1000 OBSTETRICAL IMAGER?

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

What is the FDA product code for FETA SCAN 1000 OBSTETRICAL IMAGER?

The FDA product code for FETA SCAN 1000 OBSTETRICAL IMAGER is HEM.

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Other records listing International Biomedics, 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.

K031096MODIFICATION TO TRANSPORT INCUBATOR 185K862072FETASCAN ULTRASOUND TRANSDUCER IBI# 101B00054-01K860933AIR-CUSHION TOCOTONOMETERK860295FETASCAN 1500

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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