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FDA 510(k)

DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20

K-Number: K101372 · 2010-08-10

ApplicantBaylis Medical Co., Inc.
Decision Date2010-08-10
Product CodeGXI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20 is the device name listed in this FDA 510(k) record. The listed applicant is Baylis Medical Co., Inc.. It received FDA 510(k) clearance on 2010-08-10 under 510(k) number K101372. The device is classified under product code GXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20?

DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20 is a medical device that received FDA 510(k) clearance on 2010-08-10. The listed applicant is Baylis Medical Co., Inc.. The 510(k) number is K101372.

When did DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20 receive FDA 510(k) clearance?

DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20 received FDA 510(k) clearance on 2010-08-10, under 510(k) number K101372.

Who is the listed applicant for DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20?

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

What is the FDA product code for DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20?

The FDA product code for DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20 is GXI.

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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.

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