Identity
- Trade Name
- FlowScreen FDA UDI
- Generic Name
- Diagnostic spirometer, professional FDA UDI
- Device Name
- diagnostic spirometer for recording and assessing pulmonary function FDA UDI
- Model / Reference
- FlowScreen CT FDA UDI
- Description
- diagnostic spirometer for recording and assessing pulmonary function FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04057155000122 FDA UDI
- 510(k) Number
- K080734 FDA UDI
- FDA Product Code
- BTY FDA UDI
- GMDN Term
- Diagnostic spirometer, professional FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1890 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Diagnostic spirometer, professional
FlowScreen by eResearchTechnology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- SPIROVIT SP-250 — Schiller Corp. · Class II
- Alpha — Vitalograph Ireland, Ltd. · Class II
Cleared under the same submission
K080734 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
- eResearchTechnology, Inc.
Sources (1)
- FDA UDI 56e8937b-1e5d-4e3f-8e08-d949fa15b619 35 fields · synced May 30, 2026