Identity
- Trade Name
- SpiroScout FDA UDI
- Generic Name
- Diagnostic spirometer, professional FDA UDI
- Device Name
- The SpiroScout is a PC based system designed to measure and record FVC and SV Spiro recordings for adult and paediatric patients. Measurements are made with the SpiroScout ultrasound sensor. The SpiroScout sensor is supplied with either a disposable single- use ScoutTube, or a disposable single- use PFT Bacterial filter mouthpiece assembly. A ScoutTube or PFT filter is used for every patient to help prevent patient cross contamination. The SpiroScout is available with the following Options. Tidal Breath Analysis for paediatrics Rhinomanometrie Capnovolumetry (evaluation off additional parameters during tidal breathing, see software Ganshorn.LFX) HL7/ network (network connection via software Ganshorn.LFX) FDA UDI
- Model / Reference
- 04421 FDA UDI
- Description
- The SpiroScout is a PC based system designed to measure and record FVC and SV Spiro recordings for adult and paediatric patients. Measurements are made with the SpiroScout ultrasound sensor. The SpiroScout sensor is supplied with either a disposable single- use ScoutTube, or a disposable single- use PFT Bacterial filter mouthpiece assembly. A ScoutTube or PFT filter is used for every patient to help prevent patient cross contamination. The SpiroScout is available with the following Options. Tidal Breath Analysis for paediatrics Rhinomanometrie Capnovolumetry (evaluation off additional parameters during tidal breathing, see software Ganshorn.LFX) HL7/ network (network connection via software Ganshorn.LFX) FDA UDI
Identifiers
- Catalog Number
- 04421 FDA UDI
- Primary DI / UDI-DI
- 04250972300103 FDA UDI
- 510(k) Number
- K160116 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
Yes
FDA UDI
Category: Diagnostic spirometer, professional
SpiroScout by Ganshorn Medizin Electronic GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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
K160116 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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
- Ganshorn Medizin Electronic GmbH
Sources (2)
- FDA UDI e575a874-bd0d-436b-b8f9-e02be037b989 37 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026