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FDA 510(k)

SMART WAVE GS100

K-Number: K950617 · 1995-10-13

ApplicantShotwell & Carr, Inc.
Decision Date1995-10-13
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent for Some Indications

Device Summary

SMART WAVE GS100 is the device name listed in this FDA 510(k) record. The listed applicant is Shotwell & Carr, Inc.. It received FDA 510(k) clearance on 1995-10-13 under 510(k) number K950617. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the SMART WAVE GS100?

SMART WAVE GS100 is a medical device that received FDA 510(k) clearance on 1995-10-13. The listed applicant is Shotwell & Carr, Inc.. The 510(k) number is K950617.

When did SMART WAVE GS100 receive FDA 510(k) clearance?

SMART WAVE GS100 received FDA 510(k) clearance on 1995-10-13, under 510(k) number K950617.

Who is the listed applicant for SMART WAVE GS100?

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

What is the FDA product code for SMART WAVE GS100?

The FDA product code for SMART WAVE GS100 is IPF.

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 Shotwell & Carr, 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.

K970824MDX 2000, DIGITAL ANALYZERK961011DTX-200 BONE DENSITOMETER

Related Devices (Code: IPF)

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

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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