Atlas FDA

TRANSDUCER PROTECTOR

FDA 510(k) clearance K772040 · decided 1977-11-28

Clearance details

K-number
K772040
Device name
TRANSDUCER PROTECTOR
Applicant
Terumo America, Inc.
Decision
Substantially Equivalent
Date received
1977-10-28
Decision date
1977-11-28
Days to decision
31 days
Clearance type
Traditional
Product code
FKJ
Device class
2
Regulation number
876.5820
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

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GUARDIAN™ Quick Dip Residual Chlorine (5212) (K253863)Serim Research2026-03-17
SERIM RESIDUAL CHLORINE TEST KIT (K901734)Serim Research Corp.1990-09-13
BBL GASPAK POUCH (K841307)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-05-14
J.E.T. DIALYSIS SYSTEM (K820575)Computer Dialysis Systems, Inc.1982-05-20

Recalls involving this device

No recalls on record reference this clearance.