Ccs-200 Spirometer
by Benson Medical Instruments Co.
510(k) K123896
Ccs-200 Spirometer is a medical device (FDA Class II; FDA product code BZG, Spirometer, Diagnostic) made by Benson Medical Instruments Co., cleared under FDA 510(k) K123896 on 10 Sep 2013, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK123896 | Date10 Sep 2013 | StatusActive |
Official records
- FDA 510(k) database K123896
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- BZG
- Device class
- Class II
- Regulation
- 21 CFR Part 868.1840
- Advisory committee
- Anesthesiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K123896
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| 500326-100 | 500326-100 / 500326-100 | B207500326100 | No longer on the market | |
| 500434-100 | NA / 500434-100 | B207500434100 | On the market | |
| CCS-200 | NA / CCS-200 | B2075003470 | On the market |
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Other devices filed under FDA product code BZG (Spirometer, Diagnostic).
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- FUKUNDA SANGYO UNITS ELECTRONIC SPIRO by Future Impex Corp.