FDA 510(k)

PAM 3000

K-Number: K082626 · 2009-01-16

ApplicantWireless 2000 RF & Uwb Technologies , Ltd.

Decision Date2009-01-16

Product CodeDRT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

PAM 3000 is the device name listed in this FDA 510(k) record. The listed applicant is Wireless 2000 RF & Uwb Technologies , Ltd.. It received FDA 510(k) clearance on 2009-01-16 under 510(k) number K082626. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PAM 3000?

PAM 3000 is a medical device that received FDA 510(k) clearance on 2009-01-16. The listed applicant is Wireless 2000 RF & Uwb Technologies , Ltd.. The 510(k) number is K082626.

When did PAM 3000 receive FDA 510(k) clearance?

PAM 3000 received FDA 510(k) clearance on 2009-01-16, under 510(k) number K082626.

Who is the listed applicant for PAM 3000?

The FDA 510(k) record lists Wireless 2000 RF & Uwb Technologies , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PAM 3000?

The FDA product code for PAM 3000 is DRT.

Related Devices (Code: DRT)

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.

K254058DistaSense(TM) (v1)Life Detection Technologies K261286The Circadia C300 System (C300)Circadia Health, Inc.K252676The Circadia C300 System (C300)Circadia Health, Inc.K253388Sleepiz One+ (Model 2.5)Sleepiz AG K251364Sleepiz One+ (2.5)Sleepiz AG K234003The Circadia C200 SystemCircadia Technologies, Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.