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FDA 510(k)

TETRAD MODEL 6F, END-VIEWING, ENDOCAVITY PROBE, 4.5/8.5 MHZ, CA

K-Number: K945318 · 1995-05-05

ApplicantTetra Corp.
Decision Date1995-05-05
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TETRAD MODEL 6F, END-VIEWING, ENDOCAVITY PROBE, 4.5/8.5 MHZ, CA is the device name listed in this FDA 510(k) record. The listed applicant is Tetra Corp.. It received FDA 510(k) clearance on 1995-05-05 under 510(k) number K945318. 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 TETRAD MODEL 6F, END-VIEWING, ENDOCAVITY PROBE, 4.5/8.5 MHZ, CA?

TETRAD MODEL 6F, END-VIEWING, ENDOCAVITY PROBE, 4.5/8.5 MHZ, CA is a medical device that received FDA 510(k) clearance on 1995-05-05. The listed applicant is Tetra Corp.. The 510(k) number is K945318.

When did TETRAD MODEL 6F, END-VIEWING, ENDOCAVITY PROBE, 4.5/8.5 MHZ, CA receive FDA 510(k) clearance?

TETRAD MODEL 6F, END-VIEWING, ENDOCAVITY PROBE, 4.5/8.5 MHZ, CA received FDA 510(k) clearance on 1995-05-05, under 510(k) number K945318.

Who is the listed applicant for TETRAD MODEL 6F, END-VIEWING, ENDOCAVITY PROBE, 4.5/8.5 MHZ, CA?

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

What is the FDA product code for TETRAD MODEL 6F, END-VIEWING, ENDOCAVITY PROBE, 4.5/8.5 MHZ, CA?

The FDA product code for TETRAD MODEL 6F, END-VIEWING, ENDOCAVITY PROBE, 4.5/8.5 MHZ, CA is ITX.

Related Clinical Trials

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.

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Other records listing Tetra Corp. 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.

K946277TETRAD 2300 E/U ULTRASOUNG IMAGING SYSTEMK945320TETRAD MODEL BG22, AUTOMATIC BIOPSY UNIT MODELK945319TETRAD MODEL BS18, ENDOSURGICAL NEEDLE GUIDE ATTACHMENTK924204NEW ULTRASOUND IMAGING SYSTEM & TRANSDUCERS

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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