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FDA 510(k)

OP3/VP4

K-Number: K924516 · 1993-06-28

ApplicantHuntleigh Technology, Inc.
Decision Date1993-06-28
Product CodeHGL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

OP3/VP4 is the device name listed in this FDA 510(k) record. The listed applicant is Huntleigh Technology, Inc.. It received FDA 510(k) clearance on 1993-06-28 under 510(k) number K924516. 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 OP3/VP4?

OP3/VP4 is a medical device that received FDA 510(k) clearance on 1993-06-28. The listed applicant is Huntleigh Technology, Inc.. The 510(k) number is K924516.

When did OP3/VP4 receive FDA 510(k) clearance?

OP3/VP4 received FDA 510(k) clearance on 1993-06-28, under 510(k) number K924516.

Who is the listed applicant for OP3/VP4?

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

What is the FDA product code for OP3/VP4?

The FDA product code for OP3/VP4 is HGL.

Other records listing Huntleigh Technology, Inc. as applicant

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K992733AKRON ATP9 TRACTION MACHINEK964699RHEO DOPPLEX II (RD 2)K910188FLOWPLUS AC330 PUMP GARMENTSK900882MULTI DOPPLEX, MD-1K900618HUNTLEIGH FETAL DOPPLER, FD-1 & DOPCORD, D140K890012HUNTLEIGH DYNAMIC FLOTATION SYSTEM

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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.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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