FDA 510(k)

PLUS 1

K-Number: K850478 · 1985-04-15

Decision Date1985-04-15

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

PLUS 1 is the device name listed in this FDA 510(k) record. The listed applicant is Dymax Corp. It received FDA 510(k) clearance on 1985-04-15 under 510(k) number K850478. 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 PLUS 1?

PLUS 1 is a medical device that received FDA 510(k) clearance on 1985-04-15. The listed applicant is Dymax Corp. The 510(k) number is K850478.

When did PLUS 1 receive FDA 510(k) clearance?

PLUS 1 received FDA 510(k) clearance on 1985-04-15, under 510(k) number K850478.

Who is the listed applicant for PLUS 1?

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 PLUS 1?

The FDA product code for PLUS 1 is IYO.

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 SYSTEM K993624SITE-RITE 3 ULTRASOUND SYSTEM K931403SITERITE NEEDLE GUIDE (MODIFIED)K903158SITERITE NEEDLE GUIDE K894415DYMAX ENDOVAGINAL BIOPSY GUIDE K862127DYMAX PERSONAL SCANNER

View all 7 devices →

Related Devices (Code: IYO)

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApS K252237EdgeFlow 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.