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FDA 510(k)

ORTHOSONICS DUO-SON ULTRASOUND DIATHERMY DEVICE

K-Number: K970131 · 1997-06-16

ApplicantC.L. Mcintosh & Assoc., Inc.
Decision Date1997-06-16
Product CodeIMI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ORTHOSONICS DUO-SON ULTRASOUND DIATHERMY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is C.L. Mcintosh & Assoc., Inc.. It received FDA 510(k) clearance on 1997-06-16 under 510(k) number K970131. The device is classified under product code IMI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHOSONICS DUO-SON ULTRASOUND DIATHERMY DEVICE?

ORTHOSONICS DUO-SON ULTRASOUND DIATHERMY DEVICE is a medical device that received FDA 510(k) clearance on 1997-06-16. The listed applicant is C.L. Mcintosh & Assoc., Inc.. The 510(k) number is K970131.

When did ORTHOSONICS DUO-SON ULTRASOUND DIATHERMY DEVICE receive FDA 510(k) clearance?

ORTHOSONICS DUO-SON ULTRASOUND DIATHERMY DEVICE received FDA 510(k) clearance on 1997-06-16, under 510(k) number K970131.

Who is the listed applicant for ORTHOSONICS DUO-SON ULTRASOUND DIATHERMY DEVICE?

The FDA 510(k) record lists C.L. Mcintosh & Assoc., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORTHOSONICS DUO-SON ULTRASOUND DIATHERMY DEVICE?

The FDA product code for ORTHOSONICS DUO-SON ULTRASOUND DIATHERMY DEVICE is IMI.

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 C.L. Mcintosh & Assoc., 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.

K972016AUTIMO 2.5-D AND AUTIMO 3-DK961725OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISIONK942227NICAS 2001 NONINVASIVE CARDIO-RESPIRATORY SYSTEM

Related Devices (Code: IMI)

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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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