510(k) K924487
K924487 is an FDA 510(k) premarket notification submitted by 3M Health Care, Ltd. for the device "RED DOT 2515 CARDIAC SENSOR SYSTEM". The FDA issued a decision of Substantially Equivalent on December 23, 1992. The device falls under product code BRX (Stool, Anesthesia), a Class I device regulated under 21 CFR 868.6700. 3M Health Care, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 23, 1992
- Date Received
- September 3, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stool, Anesthesia
- Device Class
- Class I
- Regulation Number
- 868.6700
- Review Panel
- AN
- Submission Type