SENTRYSUITE PRODUCT LINE

Calculator, Predicted Values, Pulmonary Function

CAREFUSION GERMANY 234 GMBH

The following data is part of a premarket notification filed by Carefusion Germany 234 Gmbh with the FDA for Sentrysuite Product Line.

Pre-market Notification Details

• Device ID: K122699
• 510k Number: K122699
• Device Name: SENTRYSUITE PRODUCT LINE
• Classification: Calculator, Predicted Values, Pulmonary Function
• Applicant: CAREFUSION GERMANY 234 GMBH LEIBNIZSTRASSE 7 Hoechberg, DE 97204
• Contact: Elmar Niedermeyer
• Correspondent: Elmar Niedermeyer; CAREFUSION GERMANY 234 GMBH LEIBNIZSTRASSE 7 Hoechberg, DE 97204
• Product Code: BTY
• Subsequent Product Code: BZC
• Subsequent Product Code: BZG
• Subsequent Product Code: JEH
• CFR Regulation Number: 868.1890 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-09-04
• Decision Date: 2012-11-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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