FDA.report

510(k) K934631

Device
TRANSWARMER
Applicant
PRISM TECHNOLOGIES, INC.
510(k) number
K934631
Product code
IMD  
Decision
Substantially Equivalent (SESE)
Decision date
1994-02-03
Date received
1993-09-24
Regulation
890.5710
Classification name
Pack, Hot Or Cold, Disposable
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
MERLE M SMITH
Address
7492 Reindeer Trl. San Antonio TX US 78238 78238

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
30888937025768TRANSWARMER INFANT TRANSPORT MATTRESSCoopersurgical, Inc.2022-11-29

Legacy Summary

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FDA Review

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