ACCULITE-PPL 5
FDA 510(k) clearance K884787 · decided 1989-01-24
Clearance details
- K-number
- K884787
- Device name
- ACCULITE-PPL 5
- Applicant
- Medical Alignment Systems
- Decision
- Substantially Equivalent
- Date received
- 1988-11-15
- Decision date
- 1989-01-24
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- INE
- Device class
- 1
- Regulation number
- 890.3910
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Sandy, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.