FDA.report

510(k) K952542

Device
ACKRAD ESOPHAGEAL BALLOON CATHETER SET
Applicant
ACKRAD LABORATORIES
510(k) number
K952542
Product code
BZC  
Decision
Substantially Equivalent (SESE)
Decision date
1996-04-23
Date received
1995-05-23
Regulation
868.1880
Classification name
Calculator, Pulmonary Function Data
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
ROBERT M LANDIS
Address
70 Jackson Dr. Cranford NJ US 07016 07016

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

Legacy Summary

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FDA Review

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