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

KONTRON CAPNOGRAPH MONITOR, SUPERMON MODULE 7281

K Number: K873396 · Decision Jun 21, 1988
Classifications
1
FEI Numbers
217
Registration Numbers
217
Same Product Code
304
Applicant Total
57
Review Days
302

Research this 510(k) in seconds

The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

Free to try · every answer cites its records

Basic Information

Device Name
KONTRON CAPNOGRAPH MONITOR, SUPERMON MODULE 7281
K Number
K873396
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
868.1400
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
Kontron Instruments, Inc.
Date Received
August 24, 1987
Decision Date
June 21, 1988
Product Code
CCK
Advisory Committee
Anesthesiology
Review Advisory Committee
AN
Third Party
N

Classifications

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

Product Code Device Name
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (CCK), ordered by most recent decision date.

View all

Other Clearances by Kontron Instruments, Inc.

K Number Device Name
K932268 MODIFICATIONS TO INTRA-AORTIC BALLOONS
K925248 MODIFICATION OF INTRA-AORTIC BALLOON CATHETERS
K923603 INTRA-AORTIC BALLOON PUMP CATHETER - MODIFICATION
K905313 KONTRON INTRA-AORTIC BALLOON PUMP, MODEL KAAT II
K903344 9.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM)
K896437 KONTRON SIGMA 44 HVCD ULTRASOUND IMAGING SYSTEM
K892222 9.5F PERCU DOUBLE LUMEN INTRA-AORTIC BALLOON
K882955 SUPERMON NEONATAL NON-INVASIVE BLOOD PRESS. 7283
K896386 MINIMON 7133B PATIENT MONITOR
K896417 KONTRON KOLORMON 7250 PATIENT MONITOR
Search all 57 clearances from Kontron Instruments, Inc. →