MOBILIMB-CPM UPPER/LOWER LIMB DEVICE— 510(k) K823495
Substantially EquivalentSynthes (Usa)
FDA 510(k) clearance K823495 for MOBILIMB-CPM UPPER/LOWER LIMB DEVICE, Substantially Equivalent on 1983-01-21. Applicant: Synthes (Usa). Device class: 1.
Clearance details
- Applicant
- Synthes (Usa)
- Product code
- Code BXB
- Device class
- Class 1
- Regulation
- 21 CFR 890.5380
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.