FDA 510(k)

CWAS 1000

K-Number: K033452 · 2003-11-28

Decision Date2003-11-28

Product CodeIKN

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

CWAS 1000 is the device name listed in this FDA 510(k) record. The listed applicant is Fasstech. It received FDA 510(k) clearance on 2003-11-28 under 510(k) number K033452. The device is classified under product code IKN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CWAS 1000?

CWAS 1000 is a medical device that received FDA 510(k) clearance on 2003-11-28. The listed applicant is Fasstech. The 510(k) number is K033452.

When did CWAS 1000 receive FDA 510(k) clearance?

CWAS 1000 received FDA 510(k) clearance on 2003-11-28, under 510(k) number K033452.

Who is the listed applicant for CWAS 1000?

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

What is the FDA product code for CWAS 1000?

The FDA product code for CWAS 1000 is IKN.

Other records listing Fasstech 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.

K063447INSIGHT DISCOVERY K023209INSIGHT MILLENNIUM III K011964INSIGHT MILLENNIUM PLUS K011983INSIGHT GENESIS K990778INSIGHT MILLENNIUM K961212SPINAL TOUCH

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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.