Substantially Equivalent 510(k) Device Information
Applicant: Microwave Medical System, Acton, MA
510(k) number: BK970044
Product: ThermoStat 900
Date: 01/23/98
Summary of Safety and Effectiveness
PREMARKET NOTIFICATION
510(K) STATEMENT
(As Required by 21 CFR 807.93)
Device: TheromStat™900 Blood and IV Fluid Warmer
I certify that, in my capacity as V.P. and Technical Director of Microwave Medical Systems, Inc., Iwill make available all information included in this premarket notification on safety and effectiveness within 30 days of the request by any person if the device described in the premarket notification submission is determined to be substantially equivalent. The information I agree to make available will be a duplicate of the premarket notification submission, including any adverse safety and effectiveness information, but excluding all patient identifiers, and trade secret and confidential commercial information, as defined in 21 CFR 20.61.
___--- signature ---
(Signature of Certifier)
__Richard S. Gabowy__
(Typed Name)
____10/30/97____
(Date)
____BK970044____
*(Premarket Notification [510(k)] Number)
* New 510(k) Supplement Notification to: BK940003
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