Atlas FDA

MACHIDA AMERICA MODEL AC-5000 AUTOMATIC DISINFECT.

FDA 510(k) clearance K871712 · decided 1988-01-14

Clearance details

K-number
K871712
Device name
MACHIDA AMERICA MODEL AC-5000 AUTOMATIC DISINFECT.
Applicant
Machida America, Inc.
Decision
Substantially Equivalent
Date received
1987-05-04
Decision date
1988-01-14
Days to decision
255 days
Clearance type
Traditional
Product code
NVE
Device class
2
Regulation number
876.1500
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Orangeburg, NY, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.