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FDA 510(k)

DYMAX PERSONAL SCANNER

K-Number: K862127 · 1986-12-11

ApplicantDymax Corp
Decision Date1986-12-11
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DYMAX PERSONAL SCANNER is the device name listed in this FDA 510(k) record. The listed applicant is Dymax Corp. It received FDA 510(k) clearance on 1986-12-11 under 510(k) number K862127. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DYMAX PERSONAL SCANNER?

DYMAX PERSONAL SCANNER is a medical device that received FDA 510(k) clearance on 1986-12-11. The listed applicant is Dymax Corp. The 510(k) number is K862127.

When did DYMAX PERSONAL SCANNER receive FDA 510(k) clearance?

DYMAX PERSONAL SCANNER received FDA 510(k) clearance on 1986-12-11, under 510(k) number K862127.

Who is the listed applicant for DYMAX PERSONAL SCANNER?

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

What is the FDA product code for DYMAX PERSONAL SCANNER?

The FDA product code for DYMAX PERSONAL SCANNER is IYO.

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Other records listing Dymax 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.

K032135SITE-RITE IV ULTRASOUND SYSTEMK993624SITE-RITE 3 ULTRASOUND SYSTEMK931403SITERITE NEEDLE GUIDE (MODIFIED)K903158SITERITE NEEDLE GUIDEK894415DYMAX ENDOVAGINAL BIOPSY GUIDEK850478PLUS 1

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Related Devices (Code: IYO)

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.

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, 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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