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Cetro America Toco Transducer for all Coro models, Waterproof
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Cetro America Toco Transducer for all Coro models, Waterproof FDA UDI
- Generic Name
- Tocodynamometer probe FDA UDI
- Device Name
- Replacement Waterproof Toco Transducer for all models of Corometrics brand fetal monitors. FDA UDI
- Model / Reference
- 8032021 FDA UDI
- Description
- Replacement Waterproof Toco Transducer for all models of Corometrics brand fetal monitors. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852519007335 FDA UDI
- 510(k) Number
- K050826 FDA UDI
- FDA Product Code
- HGM FDA UDI
- GMDN Term
- Tocodynamometer probe FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.2740 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
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Tocodynamometer probe
Cetro America Toco Transducer for all Coro models, Waterproof by Cetro America — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tocodynamometer probe.
- TOCO Transducer — Edan Instruments, Inc. · Class II
- FEATHERLITE TOCO — Parker Hannifin Corp. · Class II
- Avalon TOCO MP Transducer — Philips Medizin Systeme Böblingen GmbH · Class II
- FEATHERLITE AQUA — Parker Hannifin Corp. · Class II
- FEATHERLITE TOCO — Parker Hannifin Corp. · Class II
- FEATHERLITE TOCO PLUS — Parker Hannifin Corp. · Class II
- FEATHERLITE TOCO PLUS — Parker Hannifin Corp. · Class II
- AIV — AMERICAN I.V. PRODUCTS, INC. · Class II
Cleared under the same submission
K050826 also covers:
- Cetro America Toco Transducer for FC, FS, Fetacare — Cetro America
- Cetro America Toco Transducer for FC, FS, Fetacare, Waterproof — Cetro America
- Cetro America Toco Transducer for HP 1350+ — Cetro America
- Cetro America Toco Transducer for HP 1350+, Waterproof — Cetro America
- Cetro America Toco Transducer for HP8040 — Cetro America
- Cetro America Toco Transducer for HP8040, Waterproof — Cetro America
- Cetro America Toco Transducer for IM76/AM66 — Cetro America
- Cetro America Toco Transducer for IM76/AM66, Waterproof — Cetro America
- Cetro America Toco Transducer for IM77/AM67 — Cetro America
- Cetro America Toco Transducer for IM77/AM67, Waterproof — Cetro America
- Cetro America Toco Transducer for Oxford Sonicaid — Cetro America
- Cetro America Toco Transducer for Oxford Sonicaid, Waterproof — Cetro America
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
- Cetro America
Sources (1)
- FDA UDI d0cd0cff-518b-45bd-b141-7aae222729d1 35 fields · synced Jun 1, 2026