The following data is part of a premarket notification filed by Benson Medical Instruments Co. with the FDA for Ccs-200 Spirometer.
Device ID | K123896 |
510k Number | K123896 |
Device Name: | CCS-200 SPIROMETER |
Classification | Spirometer, Diagnostic |
Applicant | BENSON MEDICAL INSTRUMENTS CO. 310FOURTH AVE SOUTH SUITE 5000 Minneapolis, MN 55415 |
Contact | David Mayou |
Correspondent | David Mayou BENSON MEDICAL INSTRUMENTS CO. 310FOURTH AVE SOUTH SUITE 5000 Minneapolis, MN 55415 |
Product Code | BZG |
CFR Regulation Number | 868.1840 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-12-18 |
Decision Date | 2013-09-10 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B207500434100 | K123896 | 000 |
B2075003470 | K123896 | 000 |
B207500326100 | K123896 | 000 |