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FDA 510(k)

FETAL PULSE DETECTOR MODEL DOP-1

K-Number: K902190 · 1990-10-22

ApplicantAdvanced Medical Systems, Inc.
Decision Date1990-10-22
Product CodeHEK
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FETAL PULSE DETECTOR MODEL DOP-1 is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Medical Systems, Inc.. It received FDA 510(k) clearance on 1990-10-22 under 510(k) number K902190. The device is classified under product code HEK. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FETAL PULSE DETECTOR MODEL DOP-1?

FETAL PULSE DETECTOR MODEL DOP-1 is a medical device that received FDA 510(k) clearance on 1990-10-22. The listed applicant is Advanced Medical Systems, Inc.. The 510(k) number is K902190.

When did FETAL PULSE DETECTOR MODEL DOP-1 receive FDA 510(k) clearance?

FETAL PULSE DETECTOR MODEL DOP-1 received FDA 510(k) clearance on 1990-10-22, under 510(k) number K902190.

Who is the listed applicant for FETAL PULSE DETECTOR MODEL DOP-1?

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

What is the FDA product code for FETAL PULSE DETECTOR MODEL DOP-1?

The FDA product code for FETAL PULSE DETECTOR MODEL DOP-1 is HEK.

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Other records listing Advanced Medical Systems, 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.

K955931MODEL IM77 INTRAPARTUM FETAL MONITOR (MODIFICATION)K952031ULTRASOUND TRANSDUCER, MODEL US917K940898MODEL IM77 INTRAPARTUM FETAL MONITORK923335ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATIONK932278PFM PROFESSIONAL 7000 SPIROMETERK911657FETAL SCALP SPIRAL ELECTRODE

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Related Devices (Code: HEK)

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.

K060410ECHOHEART TRANSVAGINAL DOPPLER PROBESummit Doppler Systems, Inc.K883334BIODOP(TM)Diagnosis Related Systems, Inc.K771211DOPPLER (UTD-5 & UTD-6)Terumo America, 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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