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

LM2000A SURGICAL SUCTION MONITOR

K Number: K854359 · Decision Mar 3, 1986
Classifications
1
FEI Numbers
276
Registration Numbers
276
Same Product Code
47
Applicant Total
5
Review Days
125

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Basic Information

Device Name
LM2000A SURGICAL SUCTION MONITOR
K Number
K854359
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
880.6740
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Applicant
Engineering, Inc.
Date Received
October 29, 1985
Decision Date
March 3, 1986
Product Code
KDQ
Advisory Committee
General Hospital
Review Advisory Committee
HO
Third Party
N

Classifications

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

Product Code Device Name
KDQ Bottle, Collection, Vacuum

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Other Clearances by Engineering, Inc.

K Number Device Name
K881521 MODIFIED SERVO SYRINGE
K862749 LS9000 SUCTION BIOPSY NEEDLE
K862476 LS3000 CANNULA UTERINE SUCTION
K854844 LS1000 SURGICAL ASPIRATOR II