Identity
- Trade Name
- nSpire Health FDA UDI
- Generic Name
- Diagnostic spirometer, professional FDA UDI
- Device Name
- KoKo Legend II Spirometer (with printer) FDA UDI
- Model / Reference
- KoKo Legend II FDA UDI
- Description
- KoKo Legend II Spirometer (with printer) FDA UDI
Identifiers
- Catalog Number
- 315000 FDA UDI
- Primary DI / UDI-DI
- 00852417003354 FDA UDI
- 510(k) Number
- K051572 FDA UDI
- FDA Product Code
- BZG FDA UDI
- GMDN Term
- Diagnostic spirometer, professional 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
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
nSpire Health by Nspire Health, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Diagnostic spirometer, professional.
- Alpha — Vitalograph Ireland, Ltd. · Class II
- Chartis Console — Pulmonx Corporation · Class II
- Alpha — Vitalograph Ireland, Ltd. · Class II
- Pulmonx Chartis Tablet Console — Pulmonx Corporation · Class II
- Jaeger — Jaeger Medical GmbH · Class II
- Vyaire — Jaeger Medical GmbH · Class II
- SPIROVIT SP-250 — Schiller Corp. · Class II
- Alpha — Vitalograph Ireland, Ltd. · Class II
Cleared under the same submission
K051572 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nspire Health, Inc.
Sources (1)
- FDA UDI f3660911-4b29-4dcb-9c56-4c7f28f66352 35 fields · synced Jun 6, 2026