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FDA 510(k)

ULTRASOUND TRANSDUCER, MODEL US917

K-Number: K952031 · 1995-07-18

ApplicantAdvanced Medical Systems, Inc.
Decision Date1995-07-18
Product CodeHGL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ULTRASOUND TRANSDUCER, MODEL US917 is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Medical Systems, Inc.. It received FDA 510(k) clearance on 1995-07-18 under 510(k) number K952031. 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 ULTRASOUND TRANSDUCER, MODEL US917?

ULTRASOUND TRANSDUCER, MODEL US917 is a medical device that received FDA 510(k) clearance on 1995-07-18. The listed applicant is Advanced Medical Systems, Inc.. The 510(k) number is K952031.

When did ULTRASOUND TRANSDUCER, MODEL US917 receive FDA 510(k) clearance?

ULTRASOUND TRANSDUCER, MODEL US917 received FDA 510(k) clearance on 1995-07-18, under 510(k) number K952031.

Who is the listed applicant for ULTRASOUND TRANSDUCER, MODEL US917?

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

What is the FDA product code for ULTRASOUND TRANSDUCER, MODEL US917?

The FDA product code for ULTRASOUND TRANSDUCER, MODEL US917 is HGL.

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Other records listing Advanced 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.

K955931MODEL IM77 INTRAPARTUM FETAL MONITOR (MODIFICATION)K940898MODEL IM77 INTRAPARTUM FETAL MONITORK923335ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATIONK932278PFM PROFESSIONAL 7000 SPIROMETERK911657FETAL SCALP SPIRAL ELECTRODEK902190FETAL PULSE DETECTOR MODEL DOP-1

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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.

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 ResourcesK903316ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCERGe Medical Systems Information Technologies

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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