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FDA 510(k)

BIODOP(TM)

K-Number: K883334 · 1988-12-15

ApplicantDiagnosis Related Systems, Inc.
Decision Date1988-12-15
Product CodeHEK
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

BIODOP(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Diagnosis Related Systems, Inc.. It received FDA 510(k) clearance on 1988-12-15 under 510(k) number K883334. 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 BIODOP(TM)?

BIODOP(TM) is a medical device that received FDA 510(k) clearance on 1988-12-15. The listed applicant is Diagnosis Related Systems, Inc.. The 510(k) number is K883334.

When did BIODOP(TM) receive FDA 510(k) clearance?

BIODOP(TM) received FDA 510(k) clearance on 1988-12-15, under 510(k) number K883334.

Who is the listed applicant for BIODOP(TM)?

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

What is the FDA product code for BIODOP(TM)?

The FDA product code for BIODOP(TM) is HEK.

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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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.K902190FETAL PULSE DETECTOR MODEL DOP-1Advanced Medical 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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