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FDA 510(k)

HANDHELD DYNAMOMETER, MODEL #160 AND #111

K-Number: K861396 · 1986-05-02

Decision Date1986-05-02
Product CodeHRW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HANDHELD DYNAMOMETER, MODEL #160 AND #111 is the device name listed in this FDA 510(k) record. The listed applicant is Spark Instruments & Academics, Inc.. It received FDA 510(k) clearance on 1986-05-02 under 510(k) number K861396. The device is classified under product code HRW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HANDHELD DYNAMOMETER, MODEL #160 AND #111?

HANDHELD DYNAMOMETER, MODEL #160 AND #111 is a medical device that received FDA 510(k) clearance on 1986-05-02. The listed applicant is Spark Instruments & Academics, Inc.. The 510(k) number is K861396.

When did HANDHELD DYNAMOMETER, MODEL #160 AND #111 receive FDA 510(k) clearance?

HANDHELD DYNAMOMETER, MODEL #160 AND #111 received FDA 510(k) clearance on 1986-05-02, under 510(k) number K861396.

Who is the listed applicant for HANDHELD DYNAMOMETER, MODEL #160 AND #111?

The FDA 510(k) record lists Spark Instruments & Academics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HANDHELD DYNAMOMETER, MODEL #160 AND #111?

The FDA product code for HANDHELD DYNAMOMETER, MODEL #160 AND #111 is HRW.

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.

Other records listing Spark Instruments & Academics, 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.

Related Devices (Code: HRW)

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.

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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