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FDA 510(k)

FETAL DOPPLER FOR ULTRAMARK 4 AND 8

K-Number: K881329 · 1989-04-14

ApplicantAdvanced Technology Laboratories, Inc.
Decision Date1989-04-14
Product CodeHEM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FETAL DOPPLER FOR ULTRAMARK 4 AND 8 is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Technology Laboratories, Inc.. It received FDA 510(k) clearance on 1989-04-14 under 510(k) number K881329. 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 FETAL DOPPLER FOR ULTRAMARK 4 AND 8?

FETAL DOPPLER FOR ULTRAMARK 4 AND 8 is a medical device that received FDA 510(k) clearance on 1989-04-14. The listed applicant is Advanced Technology Laboratories, Inc.. The 510(k) number is K881329.

When did FETAL DOPPLER FOR ULTRAMARK 4 AND 8 receive FDA 510(k) clearance?

FETAL DOPPLER FOR ULTRAMARK 4 AND 8 received FDA 510(k) clearance on 1989-04-14, under 510(k) number K881329.

Who is the listed applicant for FETAL DOPPLER FOR ULTRAMARK 4 AND 8?

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

What is the FDA product code for FETAL DOPPLER FOR ULTRAMARK 4 AND 8?

The FDA product code for FETAL DOPPLER FOR ULTRAMARK 4 AND 8 is HEM.

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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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