The following data is part of a premarket notification filed by Klimamed Technologie Medizingerate Gmbh with the FDA for Klimamed Thermal Blankets, Including Arm Shoulder West Thermal Blanket And Leg Warmer Thermal Blanket.
| Device ID | K031728 |
| 510k Number | K031728 |
| Device Name: | KLIMAMED THERMAL BLANKETS, INCLUDING ARM SHOULDER WEST THERMAL BLANKET AND LEG WARMER THERMAL BLANKET |
| Classification | System, Thermal Regulating |
| Applicant | KLIMAMED TECHNOLOGIE MEDIZINGERATE GMBH 1380 LEAD HILL BOULEVARD SUITE 106 Roseville, CA 95661 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-04 |
| Decision Date | 2004-10-12 |
| Summary: | summary |