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FDA 510(k)

PORTA-STAT

K-Number: K843340 · 1984-11-27

ApplicantPorta-Stat, Inc.
Decision Date1984-11-27
Product CodeIWY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PORTA-STAT is the device name listed in this FDA 510(k) record. The listed applicant is Porta-Stat, Inc.. It received FDA 510(k) clearance on 1984-11-27 under 510(k) number K843340. The device is classified under product code IWY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PORTA-STAT?

PORTA-STAT is a medical device that received FDA 510(k) clearance on 1984-11-27. The listed applicant is Porta-Stat, Inc.. The 510(k) number is K843340.

When did PORTA-STAT receive FDA 510(k) clearance?

PORTA-STAT received FDA 510(k) clearance on 1984-11-27, under 510(k) number K843340.

Who is the listed applicant for PORTA-STAT?

The FDA 510(k) record lists Porta-Stat, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PORTA-STAT?

The FDA product code for PORTA-STAT is IWY.

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Related Devices (Code: IWY)

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.

K925705ACCURAD-200 SYSTEM & ACCURAD-300 PLUS SYSTEMDenar Corp.K884493HEAD HOLDING DEVICE/SLEEP APNEAX-Ray SystemsK884847MTD HEDRESTComposites Horizons, Inc.K864527DUOCEPHGary E. Hall, DdsK850197KELLER CEPHALOMETRIC DEVICEGary D. KellerK844549HEAD-SPINE STABILIZER HSS-1Imaging Accessories, 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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