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FDA 510(k)

280SL IMAGING SYSTEM TRANVAGINAL PROBES

K-Number: K864151 · 1987-03-27

ApplicantGe Medical Systems Information Technologies
Decision Date1987-03-27
Product CodeHGL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

280SL IMAGING SYSTEM TRANVAGINAL PROBES is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Information Technologies. It received FDA 510(k) clearance on 1987-03-27 under 510(k) number K864151. The device is classified under product code HGL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 280SL IMAGING SYSTEM TRANVAGINAL PROBES?

280SL IMAGING SYSTEM TRANVAGINAL PROBES is a medical device that received FDA 510(k) clearance on 1987-03-27. The listed applicant is Ge Medical Systems Information Technologies. The 510(k) number is K864151.

When did 280SL IMAGING SYSTEM TRANVAGINAL PROBES receive FDA 510(k) clearance?

280SL IMAGING SYSTEM TRANVAGINAL PROBES received FDA 510(k) clearance on 1987-03-27, under 510(k) number K864151.

Who is the listed applicant for 280SL IMAGING SYSTEM TRANVAGINAL PROBES?

The FDA 510(k) record lists Ge Medical Systems Information Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 280SL IMAGING SYSTEM TRANVAGINAL PROBES?

The FDA product code for 280SL IMAGING SYSTEM TRANVAGINAL PROBES is HGL.

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Other records listing Ge Medical Systems Information Technologies as applicant

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K120770QT GUARD PLUS ANALYSIS SYSTEMK102426CARESCAPE MODEL V100 VITAL SIGNS MONITORK09236912SL ECG ANALYSIS PROGRAMK093141MARS HOLTER ANALYSIS WORKSTATIONK092027CARESCAPE MONITOR B850K090702MODIFICATION TO DASH 2500 PATIENT MONITOR

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Related Devices (Code: HGL)

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.

K952031ULTRASOUND TRANSDUCER, MODEL US917Advanced Medical Systems, Inc.K923335ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATIONAdvanced Medical Systems, Inc.K924516OP3/VP4Huntleigh Technology, Inc.K903348ULTRASONIC PULSED DOPPLER IMAGING SYSTEMAdvanced Technology Laboratories, Inc.K900966EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBEHitachi Medical Corp. of AmericaK901142MER MULTIPLANE VAGINAL PROBE (MVP)Medical Equipment Resources

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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