GAMBRO PULSATILE MONITOR PLM 10-200
FDA 510(k) clearance K842503 · decided 1984-08-10
Clearance details
- K-number
- K842503
- Device name
- GAMBRO PULSATILE MONITOR PLM 10-200
- Applicant
- Gambro, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-06-26
- Decision date
- 1984-08-10
- Days to decision
- 45 days
- Clearance type
- Traditional
- Product code
- DWA
- Device class
- 2
- Regulation number
- 870.4380
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.