FDA 510(k)

KRDL 2000

K-Number: K944819 · 1995-03-10

Decision Date1995-03-10

Product CodeBXB

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

KRDL 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Physicians Consulting, Inc.. It received FDA 510(k) clearance on 1995-03-10 under 510(k) number K944819. The device is classified under product code BXB. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KRDL 2000?

KRDL 2000 is a medical device that received FDA 510(k) clearance on 1995-03-10. The listed applicant is Physicians Consulting, Inc.. The 510(k) number is K944819.

When did KRDL 2000 receive FDA 510(k) clearance?

KRDL 2000 received FDA 510(k) clearance on 1995-03-10, under 510(k) number K944819.

Who is the listed applicant for KRDL 2000?

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

What is the FDA product code for KRDL 2000?

The FDA product code for KRDL 2000 is BXB.

Other records listing Physicians Consulting, Inc. 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.

K952369KRD PL 2000 CONTROLLED PASSIVE MOTION (CPM) PORTABLE

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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.