Identity
- Trade Name
- PCG Transducer Package FDA UDI
- Generic Name
- Phonocardiograph FDA UDI
- Model / Reference
- 120-000194-00 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944904089737 FDA UDI
- 510(k) Number
- K103583 FDA UDI
- FDA Product Code
- IYN FDA UDI
- GMDN Term
- Phonocardiograph FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1550 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Phonocardiograph
PCG Transducer Package by Shenzhen Mindray Bio-Medical Electronics Co. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Phonocardiograph.
- HemoTag — Aventusoft L.L.C. · Class I
- Coala Heart Monitor US Rx — Coala-Life AB · Class II
- Stethee Pro Mobile Android Application — M3Dicine Pty , Ltd. · Class I
- Acarix CADScor Patch — Acarix A/S · Class II
- Acarix CADScor System — Acarix A/S · Class II
- Stethee Pro Central Web Application — M3Dicine Pty , Ltd. · Class I
- Stethee Pro Mobile iOS Application — M3Dicine Pty , Ltd. · Class I
- PCG Transducer Kit — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
Cleared under the same submission
K103583 also covers:
- 4CD4 Ultrasonic Transducer(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- 7L4A Ultrasonic Transducer(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- 7L5 Ultrasonic Transducer(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- B/W video printer(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- B/W video printer(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- C5-2 Ultrasonic Transducer(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- CB10-4 Ultrasound Probe(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- DC-7 Ultrasound system — Shenzhen Mindray Bio-Medical Electronics Co.
- DC-7T Ultrasound System — Shenzhen Mindray Bio-Medical Electronics Co.
- DE10-3 Ultrasonic Transducer(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- Footswitch (not USB port) — Shenzhen Mindray Bio-Medical Electronics Co.
- L11-4 Ultrasonic Transducer(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
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
- Shenzhen Mindray Bio-Medical Electronics Co.
Sources (1)
- FDA UDI 6f237e9a-0dc4-4ad0-a435-e086ad45bdd1 34 fields · synced May 30, 2026