Identity
- Trade Name
- Smart Pressure Controller FDA UDI
- Generic Name
- General-purpose multi-parameter bedside monitor FDA UDI
- Device Name
- SMART PRESSURE CONTROLLER FDA UDI
- Model / Reference
- PC1Q FDA UDI
- Description
- SMART PRESSURE CONTROLLER FDA UDI
Identifiers
- Catalog Number
- PC1Q FDA UDI
- Primary DI / UDI-DI
- 00690103219395 FDA UDI
- 510(k) Number
- K243781 FDA UDI
- FDA Product Code
- DQK FDA UDIDQE FDA UDIQAQ FDA UDIMUD FDA UDIDXN FDA UDIDSB FDA UDIFLL FDA UDIQMS FDA UDIOLW FDA UDI
- GMDN Term
- General-purpose multi-parameter bedside monitor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1425 FDA UDI870.1230 FDA UDI870.2210 FDA UDI870.2700 FDA UDI870.1130 FDA UDI870.2770 FDA UDI880.2910 FDA UDI870.5600 FDA UDI882.1400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
MR Unsafe FDA UDI
Category: General-purpose multi-parameter bedside monitor
Smart Pressure Controller by Edwards Lifesciences LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K243781 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
- Edwards Lifesciences LLC
Sources (1)
- FDA UDI a10d9a9b-8bda-4400-ae80-571cc0e2fb47 36 fields · synced Jun 8, 2026