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FDA 510(k)

ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION

K-Number: K923335 · 1994-07-22

ApplicantAdvanced Medical Systems, Inc.
Decision Date1994-07-22
Product CodeHGL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION 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 1994-07-22 under 510(k) number K923335. 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 TRANSUCER, MODEL US915 -- MODIFICATION?

ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION is a medical device that received FDA 510(k) clearance on 1994-07-22. The listed applicant is Advanced Medical Systems, Inc.. The 510(k) number is K923335.

When did ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION receive FDA 510(k) clearance?

ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION received FDA 510(k) clearance on 1994-07-22, under 510(k) number K923335.

Who is the listed applicant for ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION?

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 TRANSUCER, MODEL US915 -- MODIFICATION?

The FDA product code for ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION 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)K952031ULTRASOUND TRANSDUCER, MODEL US917K940898MODEL IM77 INTRAPARTUM FETAL MONITORK932278PFM 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.

K952031ULTRASOUND TRANSDUCER, MODEL US917Advanced 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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