510(k) K852455
K852455 is an FDA 510(k) premarket notification submitted by Gambro, Inc. for the device "GAMBRO DIGITAL TELETHERMOMETER TTH 10-200". The FDA issued a decision of Substantially Equivalent on September 16, 1985. The device falls under product code KRI (Accessory Equipment, Cardiopulmonary Bypass), a Class I device regulated under 21 CFR 870.4200. Gambro, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 16, 1985
- Date Received
- June 10, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessory Equipment, Cardiopulmonary Bypass
- Device Class
- Class I
- Regulation Number
- 870.4200
- Review Panel
- CV
- Submission Type