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FDA 510(k)

TOITU FETAL ACTOCARDIOGRAPH, MT-332

K-Number: K894036 · 1989-11-06

ApplicantToitu of America, Inc.
Decision Date1989-11-06
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

TOITU FETAL ACTOCARDIOGRAPH, MT-332 is the device name listed in this FDA 510(k) record. The listed applicant is Toitu of America, Inc.. It received FDA 510(k) clearance on 1989-11-06 under 510(k) number K894036. The device is classified under product code HGM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOITU FETAL ACTOCARDIOGRAPH, MT-332?

TOITU FETAL ACTOCARDIOGRAPH, MT-332 is a medical device that received FDA 510(k) clearance on 1989-11-06. The listed applicant is Toitu of America, Inc.. The 510(k) number is K894036.

When did TOITU FETAL ACTOCARDIOGRAPH, MT-332 receive FDA 510(k) clearance?

TOITU FETAL ACTOCARDIOGRAPH, MT-332 received FDA 510(k) clearance on 1989-11-06, under 510(k) number K894036.

Who is the listed applicant for TOITU FETAL ACTOCARDIOGRAPH, MT-332?

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

What is the FDA product code for TOITU FETAL ACTOCARDIOGRAPH, MT-332?

The FDA product code for TOITU FETAL ACTOCARDIOGRAPH, MT-332 is HGM.

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Other records listing Toitu of America, 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.

K890139TOITU DOPPLER FETUS DETECTOR, FD-400D

Related Devices (Code: HGM)

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.

K254036Novii+ Wireless Patch SystemDatex Ohmeda, Inc.K253021ANNE MaternalSibel Health, Inc.K250777Sonicaid Team3Huntleigh Healthcare , Ltd.K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.K241368Sonicaid Team3Huntleigh Healthcare , Ltd.K241009PeriCALM Patterns 3.0Perigen, Inc.

Official Source

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