Identity
- Trade Name
- SpiroScout SP plus FDA UDI
- Generic Name
- Diagnostic spirometer, professional FDA UDI
- Device Name
- The SpiroScout SP plus is intended exclusively for use with the following SCHILLER devices. CARDIOVIT CS-104 SPIROVIT SP-1 G2 CARDIOVIT AT-102 G2 The SpiroScout SP plus is an ultrasonic measuring system which is used for pulmonary function diagnostics. It determines the transit times of the ultrasonic signals and can be used with the above-mentioned Schiller devices to measure and analyse respiratory flow and volume. FDA UDI
- Model / Reference
- Rev.D FDA UDI
- Description
- The SpiroScout SP plus is intended exclusively for use with the following SCHILLER devices. CARDIOVIT CS-104 SPIROVIT SP-1 G2 CARDIOVIT AT-102 G2 The SpiroScout SP plus is an ultrasonic measuring system which is used for pulmonary function diagnostics. It determines the transit times of the ultrasonic signals and can be used with the above-mentioned Schiller devices to measure and analyse respiratory flow and volume. FDA UDI
Identifiers
- Catalog Number
- 013400563 FDA UDI
- Primary DI / UDI-DI
- 04250972300172 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 SP plus by Ganshorn Medizin Electronic GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Diagnostic spirometer, professional.
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- SPIROVIT SP-250 — Schiller Corp. · Class II
- Alpha — Vitalograph Ireland, Ltd. · Class II
Cleared under the same submission
K160116 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
- Ganshorn Medizin Electronic GmbH
Sources (1)
- FDA UDI dd73f5eb-f1bc-428f-bfe7-901e4230490b 37 fields · synced Jun 1, 2026