Identity
- Trade Name
- PulmoScan FDA UDI
- Generic Name
- Pulmonary function analysis system, adult FDA UDI
- Device Name
- PulmoScan is a portable wireless respiratory mechanics (resistance and reactance) measurement device based on Forced Oscillometry. Bluetooth connectivity allows remote monitoring and visualization on mobile devices. FDA UDI
- Model / Reference
- PulmoScan-FOT FDA UDI
- Description
- PulmoScan is a portable wireless respiratory mechanics (resistance and reactance) measurement device based on Forced Oscillometry. Bluetooth connectivity allows remote monitoring and visualization on mobile devices. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860003953716 FDA UDI
- 510(k) Number
- K191876 FDA UDI
- FDA Product Code
- PNV FDA UDI
- GMDN Term
- Pulmonary function analysis system, adult 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Pulmonary function analysis system, adultPulmonary function analysis system, paediatric
PulmoScan by Cognita Labs Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pulmonary function analysis system, paediatric.
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- Vyaire — Jaeger Medical GmbH · Class II
- Vyaire — Jaeger Medical GmbH · Class II
- Innocor — Innovision ApS · Class II
- Vyaire — Jaeger Medical GmbH · Class II
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
- Cognita Labs Llc
Sources (1)
- FDA UDI d5b92833-19c1-41f0-bff3-4832d65d6d43 34 fields · synced Jun 8, 2026