KP + LFM
FDA 510(k) clearance K013489 · decided 2001-11-29
Clearance details
- K-number
- K013489
- Device name
- KP + LFM
- Applicant
- Pds Healthcare Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-10-22
- Decision date
- 2001-11-29
- Days to decision
- 38 days
- Clearance type
- Traditional
- Product code
- BZH
- Device class
- 2
- Regulation number
- 868.1860
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Louisville, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.