EasyOne Air Spirometer
510(k) K161536
EasyOne Air Spirometer is a medical device (FDA Class II; FDA product code BZG, Spirometer, Diagnostic) made by NDD Medizintechnik AG, cleared under FDA 510(k) K161536 on 5 Jan 2017, 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 | NumberK161536 | Date5 Jan 2017 | StatusActive |
Official records
- FDA 510(k) database K161536
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- Withdrawn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 K161536
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 | |||
|---|---|---|---|---|
| EasyOne Air Diagnostic Spirometer 2500 | 2500 | 07640142190431 | — | On the market |
| Henry Schein 5700683 | 5700683 / 5700683 | 00304040061954 | — | On the market |
| McKesson 141-2500-2 | 141-2500-2 | 10612479220451 | — | On the market |
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Other devices filed under FDA product code BZG (Spirometer, Diagnostic).
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