FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

PHIPIOLOGICAL SYNCHRONIZER PART#205

K Number: K781681 · Decision Oct 17, 1978
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
26
Applicant Total
7
Review Days
15

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Basic Information

Device Name
PHIPIOLOGICAL SYNCHRONIZER PART#205
K Number
K781681
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
892.1980
Medical Specialty
Radiology
Decision
Substantially Equivalent
Applicant
Brattle Instrument Corp.
Date Received
October 2, 1978
Decision Date
October 17, 1978
Product Code
IXQ
Advisory Committee
Radiology
Review Advisory Committee
RA
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
IXQ Table, Radiographic, Stationary Top

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K Number Device Name
K810588 SYNCHRONIZER #208
K802978 TRANSCUTANEOUS BLOOD OXYGEN MONITOR #300
K770692 MONITOR, FETAL, NO. L04-1100
K770296 FETAL MONITOR, PART #101-11009
K770295 ABDOMINAL ECG PROCESSOR FOR FETAL MONI.
K770297 FETAL MONITOR, PART #100-11009