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FDA 510(k)

SONOACE 88 PORTABLE ULTRASOUND SCANNER

K-Number: K900505 · 1990-08-10

ApplicantMedison Co., Ltd.
Decision Date1990-08-10
Product CodeHEM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SONOACE 88 PORTABLE ULTRASOUND SCANNER is the device name listed in this FDA 510(k) record. The listed applicant is Medison Co., Ltd.. It received FDA 510(k) clearance on 1990-08-10 under 510(k) number K900505. 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 SONOACE 88 PORTABLE ULTRASOUND SCANNER?

SONOACE 88 PORTABLE ULTRASOUND SCANNER is a medical device that received FDA 510(k) clearance on 1990-08-10. The listed applicant is Medison Co., Ltd.. The 510(k) number is K900505.

When did SONOACE 88 PORTABLE ULTRASOUND SCANNER receive FDA 510(k) clearance?

SONOACE 88 PORTABLE ULTRASOUND SCANNER received FDA 510(k) clearance on 1990-08-10, under 510(k) number K900505.

Who is the listed applicant for SONOACE 88 PORTABLE ULTRASOUND SCANNER?

The FDA 510(k) record lists Medison Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SONOACE 88 PORTABLE ULTRASOUND SCANNER?

The FDA product code for SONOACE 88 PORTABLE ULTRASOUND SCANNER is HEM.

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Other records listing Medison Co., Ltd. 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.

K103397ACCUVIX XG DIAGNOSTIC ULTRASOUND SYSTEMK103722THE SONOACE R5 DIAGNOSTIC ULTRASOUND SYSTEMK102065SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEMK101455EKO 7 DIAGNOSTIC ULTRASOUND SYSTEMK101829THE SONOACE R3 DIAGNOSTIC ULTRASOUND SYSTEMK100186MYSONO U5 DIAGNOSTIC ULTRASOUND SYSTEM

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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.K900271MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINKDigisonics, Inc.K890637EXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGEElscint, 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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