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FDA 510(k)

IMEX DOP-TONE II

K-Number: K901593 · 1990-07-02

ApplicantImex Medical Systems, Inc.
Decision Date1990-07-02
Product CodeKNG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

IMEX DOP-TONE II is the device name listed in this FDA 510(k) record. The listed applicant is Imex Medical Systems, Inc.. It received FDA 510(k) clearance on 1990-07-02 under 510(k) number K901593. The device is classified under product code KNG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMEX DOP-TONE II?

IMEX DOP-TONE II is a medical device that received FDA 510(k) clearance on 1990-07-02. The listed applicant is Imex Medical Systems, Inc.. The 510(k) number is K901593.

When did IMEX DOP-TONE II receive FDA 510(k) clearance?

IMEX DOP-TONE II received FDA 510(k) clearance on 1990-07-02, under 510(k) number K901593.

Who is the listed applicant for IMEX DOP-TONE II?

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

What is the FDA product code for IMEX DOP-TONE II?

The FDA product code for IMEX DOP-TONE II is KNG.

Other records listing Imex 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.

K973556IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9000K973562IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9100K973336IMEX STETHODOPK970156IMEX FUTURALDOP PROK942243IMEX 8000 PERSONAL CASCULAR LABK944196IMWXDOP IR

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Related Devices (Code: KNG)

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.

K252669Fetal Doppler U8-25, U9-25Zhongshan Xiaolan Town Senlan Electronic FactoryK242846Doppler FHR Detector (BF-500D+, BF-560)Shenzhen Bestman Instrument Co., Ltd.K233823Ultrasonic Fetal DopplerShenzhen Jamr Technology Co., Ltd.K232893Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)Contec Medical Systems Co.,LtdK220245Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)Contec Medical Systems Co.,LtdK211940Fetal DopplerShenzhen Taikang Medical Equipment Co., Ltd.

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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