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
- No
Applicant Contact#
- Contact
- NICOLE M CLARK
- Address
- 1500 Waukegan Rd. Bldg. K Mcgaw Park IL US 60085 60085
FDA Registration Numbers#
- 3017417635
- 3031232535
- 3027157200
- 2248903
- 1835458
- 3006008854
- 3012865799
- 3017619379
- 3013865802
- 3011248163
- 3015277818
- 3012241417
- 1216677
- 1034116
- 3013684902
- 1422399
- 2082295
- 3005113602
- 3023141635
- 3007649424
- 3010409218
- 3012316249
- 3006416350
- 2320762
- 3008693666
- 8030607
- 3010595009
- 3042284335
- 3004201320
- 3014982528
- 3018387315
- 3012777736
- 1121142
- 9616096
- 3011118556
- 3018326554
- 3034629348
- 3031256651
- 3006455037
- 3044150131
- 3007187674
- 3045058049
- 3010966625
- 3016195105
- 1836546
- 3011182985
- 3005460813
- 3024891479
- 3040274588
- 3006707030
- 1060934
- 3025440611
- 3008048783
- 3022833366
- 3022147580
- 3011689956
- 3007299770
- 3011298700
- 3007593958
- 3029952416
- 3032619573
- 9680222
- 3016955900
- 3004857344
- 2183416
- 3005569927
- 3021590259
- 3003255790
- 3019804885
- 9681544
- 3025194213
- 3016096058
- 3043654665
- 2214133
- 3020978033
- 3000268902
- 3017591220
- 3034694939
- 3017896419
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IMD#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K221653 | InfaTherm Disposable Infant Warming Mattress | International Biomedical | 2022-10-06 |
| K163295 | Infant Transport Mattress Warmer with Disc | Rapid Aid Corp. | 2017-07-24 |
| K112547 | NEO NEST | Denovo Proucts, LLC | 2012-03-06 |
| K082087 | EYEFEEL OPHTHALMIC WARMER | Bio-Lipid, Inc. | 2008-09-11 |
| K071710 | BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS) | Johnson & Johnson Consumer Products, Inc. | 2007-08-14 |
| K021843 | EYEFEEL OPHTHALMIC WARMER | Bio-Lipid, Inc. | 2002-09-03 |
| K982652 | ALLEGIANCE PORTA-WARM MATTRESS | Allegiance Healthcare Corp. | 1999-01-21 |
| K980509 | DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS | Deroyal Industries, Inc. | 1998-02-26 |
| K974190 | CP&S INSTANT COLD PACK LIMB KIT TRANSPORTER | Consolidated Products & Services, Inc. | 1997-11-19 |
| K973770 | ALLEGIANCE KWIK HEAT WARM PERINEAL PACK | Allegiance Healthcare Corp. | 1997-11-13 |
| K970399 | KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD) | Allegiance Healthcare Corp. | 1997-04-03 |
| K963689 | RECOVER ADULT VEIN WARMER | Florida Medical Industries, Inc. | 1996-12-12 |
| K963768 | INSTANT HOT PACKS | Kick Ice, Inc. | 1996-11-25 |
| K963666 | INSTANT COLD PACK | Kick Ice, Inc. | 1996-10-30 |
| K963220 | TEMPRA COLD PACK, REORDER NO. TC150 | Tempo Technology, Inc. | 1996-10-10 |