Easy on-Pc Spirometer
510(k) K090034
Easy on-Pc Spirometer is a medical device (FDA Class II; FDA product code BZG, Spirometer, Diagnostic) made by Ndd Medizitechnik AG, cleared under FDA 510(k) K090034 on 2 Jun 2009, 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 | NumberK090034 | Date2 Jun 2009 | StatusActive |
Official records
- FDA 510(k) database K090034
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- Withdrawn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 K090034
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 | |||
|---|---|---|---|---|
| Easy on-PC 2700-3 | 2700-3 / 2700-3 | 07640142190301 | — | On the market |
| McKesson 796 | 796 | 20612479194438 | — | On the market |
Similar devices
Other devices filed under FDA product code BZG (Spirometer, Diagnostic).
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- SPIROTEQ by System Analysis Corp.
- Flowhandy ZAN100 USB by Zan Messgerate GmbH
- Sensaire Diagnostic Spirometer by Qrs Diagnostic, LLC
- PM-80 Pulmotester by Future Impex Corp.
- SPM-300 Spirometer by Bionet Co., Ltd.
- B-1000 Spirometer by Biotrine Corp.