INFRARED HEATING DEVICE
FDA 510(k) clearance K140865 · decided 2014-09-03
Clearance details
- K-number
- K140865
- Device name
- INFRARED HEATING DEVICE
- Applicant
- Pro Medical Supplies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-04-03
- Decision date
- 2014-09-03
- Days to decision
- 153 days
- Clearance type
- Traditional
- Product code
- ILY
- Device class
- 2
- Regulation number
- 890.5500
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Shanghai, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.