APOLLO IR HEAT LAMP SYSTEM
FDA 510(k) clearance K060134 · decided 2006-03-21
Clearance details
- K-number
- K060134
- Device name
- APOLLO IR HEAT LAMP SYSTEM
- Applicant
- Apollo Physical Therapy Products International
- Decision
- Substantially Equivalent
- Date received
- 2006-01-18
- Decision date
- 2006-03-21
- Days to decision
- 62 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
| Record | Firm | Date |
|---|---|---|
| Apollo (cold) Laser Desktop Control Units, Model AP2-DT. The Apollo IR Heat Lamp System is recall (Z-1250-2015) | Pivotal Health Solutions | 2015-03-06 |