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FDA 510(k)

CAAS II

K-Number: K945540 · 1995-06-28

ApplicantPie Medical Equipment B.V.
Decision Date1995-06-28
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CAAS II 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 1995-06-28 under 510(k) number K945540. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAAS II?

CAAS II is a medical device that received FDA 510(k) clearance on 1995-06-28. The listed applicant is Pie Medical Equipment B.V.. The 510(k) number is K945540.

When did CAAS II receive FDA 510(k) clearance?

CAAS II received FDA 510(k) clearance on 1995-06-28, under 510(k) number K945540.

Who is the listed applicant for CAAS II?

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 CAAS II?

The FDA product code for CAAS II is IZI.

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 OPTIONK915647DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC250K912819SC1150 CW/PDK911584DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC480K911043HEMISPHERE MULTIPLANE ENDORECTAL PROBEK9110447.5 MHZ APAS TRANSDUCER (ART.NOL: 50.04918.1)

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Related Devices (Code: IZI)

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.

K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker EndoscopyK253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage CorporationK243645IC-Flow™ Imaging System 2.0Diagnostic Green GmbHK243077Affirm 800Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)K231986Modus IRSynaptive Medical, Inc.K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)Surgvision GmbH

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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