Atlas FDA

HRK-63-16 KNEE ARRAY COIL, HRK-127-16 KNEE ARRAY COIL

FDA 510(k) clearance K082987 · decided 2008-11-06

Clearance details

K-number
K082987
Device name
HRK-63-16 KNEE ARRAY COIL, HRK-127-16 KNEE ARRAY COIL
Applicant
Invivo
Decision
Substantially Equivalent
Date received
2008-10-07
Decision date
2008-11-06
Days to decision
30 days
Clearance type
Special
Product code
MOS
Device class
2
Regulation number
892.1000
Medical specialty
Radiology
Advisory committee
Radiology
Location
Florida, FL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.