SSIR SYSTEM
FDA 510(k) clearance K014208 · decided 2002-07-02
Clearance details
- K-number
- K014208
- Device name
- SSIR SYSTEM
- Applicant
- Russian-American Technology Associates, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-12-21
- Decision date
- 2002-07-02
- Days to decision
- 193 days
- Clearance type
- Traditional
- Product code
- ILY
- Device class
- 2
- Regulation number
- 890.5500
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Houston, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.