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FDA 510(k)

BIFOCAL 3.0MHZ

K-Number: K833224 · 1983-11-29

ApplicantAdr Ultrasound
Decision Date1983-11-29
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BIFOCAL 3.0MHZ is the device name listed in this FDA 510(k) record. The listed applicant is Adr Ultrasound. It received FDA 510(k) clearance on 1983-11-29 under 510(k) number K833224. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIFOCAL 3.0MHZ?

BIFOCAL 3.0MHZ is a medical device that received FDA 510(k) clearance on 1983-11-29. The listed applicant is Adr Ultrasound. The 510(k) number is K833224.

When did BIFOCAL 3.0MHZ receive FDA 510(k) clearance?

BIFOCAL 3.0MHZ received FDA 510(k) clearance on 1983-11-29, under 510(k) number K833224.

Who is the listed applicant for BIFOCAL 3.0MHZ?

The FDA 510(k) record lists Adr Ultrasound as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIFOCAL 3.0MHZ?

The FDA product code for BIFOCAL 3.0MHZ is ITX.

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Other records listing Adr Ultrasound 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.

K840408LINEAR ARRAY TRANSDUCER OR SCANHEADK834141ULTRASOUND SCAN HEAD 3.5 MHZK828049ADR ULTRASOUND MC2 LARGE CARTK828053ADR ULTRASOUND 5.5 MHZ SHORT FOCUS TRANSDUCERK828051ADR ULTRASOUND MODEL 4000 SC OR 4000 S/LCK828050ADR ULTRASOUND MODEL 4000 L

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Related Devices (Code: ITX)

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.

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, 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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