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FDA 510(k)

GREENLEAF EVAL SYSTEM/ GREENLEAF SOLOSYSTEM

K-Number: K935757 · 1994-04-15

ApplicantGreenleaf Medical Systems, Inc.
Decision Date1994-04-15
Product CodeLBB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GREENLEAF EVAL SYSTEM/ GREENLEAF SOLOSYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Greenleaf Medical Systems, Inc.. It received FDA 510(k) clearance on 1994-04-15 under 510(k) number K935757. The device is classified under product code LBB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GREENLEAF EVAL SYSTEM/ GREENLEAF SOLOSYSTEM?

GREENLEAF EVAL SYSTEM/ GREENLEAF SOLOSYSTEM is a medical device that received FDA 510(k) clearance on 1994-04-15. The listed applicant is Greenleaf Medical Systems, Inc.. The 510(k) number is K935757.

When did GREENLEAF EVAL SYSTEM/ GREENLEAF SOLOSYSTEM receive FDA 510(k) clearance?

GREENLEAF EVAL SYSTEM/ GREENLEAF SOLOSYSTEM received FDA 510(k) clearance on 1994-04-15, under 510(k) number K935757.

Who is the listed applicant for GREENLEAF EVAL SYSTEM/ GREENLEAF SOLOSYSTEM?

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

What is the FDA product code for GREENLEAF EVAL SYSTEM/ GREENLEAF SOLOSYSTEM?

The FDA product code for GREENLEAF EVAL SYSTEM/ GREENLEAF SOLOSYSTEM is LBB.

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 Greenleaf Medical Systems, 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.

K943929DATAGLOVE AND MOVEMENT ANALYSIS SYSTEM (MAS)K893537GREENLEAF HAND IMPAIRMENT EVALUATION SYSTEMK884723(DATAGLOVE) HAND IMPAIRMENT EVALUATION SYSTEM

Related Devices (Code: LBB)

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.

K162412Hoggan Scientific® microFET2™Hoggan Scientific, LLCK073154FACTS HAND AND PINCH GRIP COMBOGlobal Services Group, LLCK052309DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006Saehan Corp.K042889DYNAMOMETER - MODEL FCE AND MODEL MSCAmetekK012492KADANCE 2000Kada Research, Inc.K981730DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 002Nk Biotechnical Corp.

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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