Identity
- Trade Name
- ABYSSAL FDA UDI
- Generic Name
- Electrocardiography monitoring system receiver FDA UDI
- Model / Reference
- NP-6030 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04947507000163 FDA UDI
- 510(k) Number
- K020084 FDA UDI
- FDA Product Code
- MHX FDA UDI
- GMDN Term
- Electrocardiography monitoring system receiver FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1025 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: Electrocardiography monitoring system receiver
Abyssal by Abyssal, K.k. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K020084 also covers:
- Abyssal — ABYSSAL, K.K.
- Abyssal — ABYSSAL, K.K.
- Abyssal — ABYSSAL, K.K.
- Abyssal — ABYSSAL, K.K.
- FUKUDA DENSHI — Fukuda Denshi Co., Ltd.
- FUKUDA DENSHI — Fukuda Denshi Co., Ltd.
- FUKUDA DENSHI — Fukuda Denshi Co., Ltd.
- FUKUDA DENSHI — Fukuda Denshi Co., Ltd.
- FUKUDA DENSHI — Fukuda Denshi Co., Ltd.
- FUKUDA DENSHI — Fukuda Denshi Co., Ltd.
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
- Abyssal, K.k.
Sources (1)
- FDA UDI 7d87fc58-f84d-41bc-bf2d-9c4d71605904 33 fields · synced Jun 8, 2026