Identity
- Trade Name
- Ergofilter FDA UDI
- Generic Name
- Pulmonary function testing filter/mouthpiece FDA UDI
- Device Name
- accessory to active diagnostic devices: FIM Spirometers FDA UDI
- Model / Reference
- SP1 FDA UDI
- Description
- accessory to active diagnostic devices: FIM Spirometers FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03760253450638 FDA UDI
- 510(k) Number
- K161676 FDA UDI
- FDA Product Code
- BZG FDA UDI
- GMDN Term
- Pulmonary function testing filter/mouthpiece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1840 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Pulmonary function testing filter/mouthpiece
Ergofilter by FIM Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K161676 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- FIM Medical
Sources (1)
- FDA UDI 5589bc4e-df0b-427a-b74b-63f409049abd 35 fields · synced Jun 1, 2026