Mini-Logger Series 2000

FDA 510(k) K991045 · Mini-Mitter Co., Inc.

Substantially Equivalent

510(k) numberK991045

Submission

Device name
Mini-Logger Series 2000
Applicant
Mini-Mitter Co., Inc.
Sunriver, OR, US
Received
March 29, 1999
Decision date
September 21, 1999
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GWK – Conditioner, Signal, Physiological
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1845
Specialty
Neurology

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K872290Bio-Logic BankerGWK · Traditional Bio-Logic Systems Corp.10/06/1987SE
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Questions and answers

When was Mini-Logger Series 2000 cleared by the FDA?

Mini-Logger Series 2000 (K991045) received a 510(k) decision of Substantially Equivalent on September 21, 1999, 176 days after the submission was received.

What is the product code of K991045?

The FDA product code is GWK – Conditioner, Signal, Physiological, a Class II (moderate risk) device regulated under 21 CFR 882.1845.