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510(k) K062754

Device
GAS MODULE SE, MODEL 0998-00-0481-02
Applicant
Datascope Corp.
510(k) number
K062754
Product code
BZK
Decision
Substantially Equivalent (SESE)
Decision date
2006-11-02
Date received
2006-09-14
Regulation
868.1850
Classification name
Spirometer, Monitoring (W/Wo Alarm)
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
KATHLEEN KRAMER
Address
800 Macarthur Blvd. Mahwh NJ US 07430 07430

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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