POLYMAP PWR-08-03
FDA 510(k) clearance K070559 · decided 2007-06-29
Clearance details
- K-number
- K070559
- Device name
- POLYMAP PWR-08-03
- Applicant
- Polymap Wireless
- Decision
- Substantially Equivalent
- Date received
- 2007-02-27
- Decision date
- 2007-06-29
- Days to decision
- 122 days
- Clearance type
- Abbreviated
- Product code
- NBW
- Device class
- 2
- Regulation number
- 862.1345
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Tucson, AZ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.