510(k) K061023
K061023 is an FDA 510(k) premarket notification submitted by Life Recovery Systems Hd, LLC for the device "THERMOSUIT SYSTEM". The FDA issued a decision of Substantially Equivalent on September 20, 2006. The device falls under product code NZE (Hyperthermia Monitor), a Class II device regulated under 21 CFR 870.5900.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 20, 2006
- Date Received
- April 13, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hyperthermia Monitor
- Device Class
- Class II
- Regulation Number
- 870.5900
- Review Panel
- CV
- Submission Type
Intended to monitor and reduce a patient's temperature to mild hypothermia (not to go below 32 degrees celsius. To induce mild hypothermia in hyperthermic patients e.g., heat stroke, fever (excluding fever related to head injury, cardiac arrest, or other severe medical conditions).