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 |