HBO CABLE ASSEMBLY, RADIOMETER TC-02
FDA 510(k) clearance K905225 · decided 1991-04-10
Clearance details
- K-number
- K905225
- Device name
- HBO CABLE ASSEMBLY, RADIOMETER TC-02
- Applicant
- Sechrist
- Decision
- Substantially Equivalent
- Date received
- 1990-11-20
- Decision date
- 1991-04-10
- Days to decision
- 141 days
- Clearance type
- Traditional
- Product code
- LKD
- Device class
- 2
- Regulation number
- 868.2480
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Anaheim, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.