ARP RX100
FDA 510(k) clearance K093259 · decided 2009-12-17
Clearance details
- K-number
- K093259
- Device name
- ARP RX100
- Applicant
- Arp Manufacturing, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-10-19
- Decision date
- 2009-12-17
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- IPF
- Device class
- 2
- Regulation number
- 890.5850
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Boulder, CO, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.