LTV 1000
FDA 510(k) clearance K984056 · decided 1999-04-12
Clearance details
- K-number
- K984056
- Device name
- LTV 1000
- Applicant
- Pulmonetic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-11-13
- Decision date
- 1999-04-12
- Days to decision
- 150 days
- Clearance type
- Traditional
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Colton, CA, US
- Third-party review
- No
- Expedited review
- No
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