PALL EC PLUS FILTER
FDA 510(k) clearance K834380 · decided 1984-08-03
Clearance details
- K-number
- K834380
- Device name
- PALL EC PLUS FILTER
- Applicant
- Pall Biomedical Products Co.
- Decision
- Substantially Equivalent
- Date received
- 1983-12-14
- Decision date
- 1984-08-03
- Days to decision
- 233 days
- Clearance type
- Traditional
- Product code
- DTM
- Device class
- 2
- Regulation number
- 870.4260
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Pall Biomedical Products Co.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.