RED DOT 2515 CARDIAC SENSOR SYSTEM
FDA 510(k) clearance K924487 · decided 1992-12-23
Clearance details
- K-number
- K924487
- Device name
- RED DOT 2515 CARDIAC SENSOR SYSTEM
- Applicant
- 3M Health Care, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1992-09-03
- Decision date
- 1992-12-23
- Days to decision
- 111 days
- Clearance type
- Traditional
- Product code
- BRX
- Device class
- 1
- Regulation number
- 868.6700
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- St. Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.