Atlas FDA

SDMO APPLICATOR CODE: ASN.8236

FDA 510(k) clearance K921961 · decided 1992-07-01

Clearance details

K-number
K921961
Device name
SDMO APPLICATOR CODE: ASN.8236
Applicant
Medi-Physics Inc. Dba Nycomed Amersham Imaging
Decision
Substantially Equivalent
Date received
1992-04-27
Decision date
1992-07-01
Days to decision
65 days
Clearance type
Traditional
Product code
IWJ
Device class
1
Regulation number
892.5650
Medical specialty
Radiology
Advisory committee
Radiology
Location
Arlington Heights, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.