FDA.report

510(k) K950680

Device
INFANT HEEL WARMER
Applicant
Baxter Healthcare Corp
510(k) number
K950680
Product code
IMD
Decision
Substantially Equivalent for Some Indications (SN)
Decision date
1995-08-23
Date received
1995-02-14
Regulation
890.5710
Classification name
Pack, Hot Or Cold, Disposable
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
1
Clearance type
Traditional
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
NICOLE M CLARK
Address
1500 Waukegan Rd. Bldg. K Mcgaw Park IL US 60085 60085

FDA Registration Numbers

Source Documents

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

Other 510(k) Records For Product Code IMD

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K112547NEO NESTDenovo Proucts, LLC2012-03-06
K082087EYEFEEL OPHTHALMIC WARMERBio-Lipid, Inc.2008-09-11
K071710BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS)Johnson & Johnson Consumer Products, Inc.2007-08-14
K021843EYEFEEL OPHTHALMIC WARMERBio-Lipid, Inc.2002-09-03
K982652ALLEGIANCE PORTA-WARM MATTRESSAllegiance Healthcare Corp.1999-01-21
K980509DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESSDeroyal Industries, Inc.1998-02-26
K974190CP&S INSTANT COLD PACK LIMB KIT TRANSPORTERConsolidated Products & Services, Inc.1997-11-19
K973770ALLEGIANCE KWIK HEAT WARM PERINEAL PACKAllegiance Healthcare Corp.1997-11-13
K970399KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD)Allegiance Healthcare Corp.1997-04-03
K963689RECOVER ADULT VEIN WARMERFlorida Medical Industries, Inc.1996-12-12
K963768INSTANT HOT PACKSKick Ice, Inc.1996-11-25
K963666INSTANT COLD PACKKick Ice, Inc.1996-10-30
K963220TEMPRA COLD PACK, REORDER NO. TC150Tempo Technology, Inc.1996-10-10