FDA 510(k)

SC1150 CW/PD

K-Number: K912819 · 1992-01-09

Decision Date1992-01-09

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SC1150 CW/PD is the device name listed in this FDA 510(k) record. The listed applicant is Pie Medical Equipment B.V.. It received FDA 510(k) clearance on 1992-01-09 under 510(k) number K912819. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SC1150 CW/PD?

SC1150 CW/PD is a medical device that received FDA 510(k) clearance on 1992-01-09. The listed applicant is Pie Medical Equipment B.V.. The 510(k) number is K912819.

When did SC1150 CW/PD receive FDA 510(k) clearance?

SC1150 CW/PD received FDA 510(k) clearance on 1992-01-09, under 510(k) number K912819.

Who is the listed applicant for SC1150 CW/PD?

The FDA 510(k) record lists Pie Medical Equipment B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SC1150 CW/PD?

The FDA product code for SC1150 CW/PD is IYN.

Other records listing Pie Medical Equipment B.V. 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.

K982203CAAS II LVA BIPLANE OPTION K945540CAAS II K915647DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC250 K911584DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC480 K911043HEMISPHERE MULTIPLANE ENDORECTAL PROBE K9110447.5 MHZ APAS TRANSDUCER (ART.NOL: 50.04918.1)

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Related Devices (Code: IYN)

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.