FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
VICKERS MEDICAL MODEL 271 HEART RATE MONITOR
K Number: K854597
·
Decision May 9, 1986
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
338
Applicant Total
5
Review Days
172
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Basic Information
- Device Name
- VICKERS MEDICAL MODEL 271 HEART RATE MONITOR
- K Number
- K854597
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Vickers , Ltd.
- Date Received
- November 18, 1985
- Decision Date
- May 9, 1986
- Product Code
- DRT
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | FDA class 2 | Cardiovascular |
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Other Clearances by Vickers , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K870330 | SP55 SYRINGE PUMP | Jun 15, 1987 | Substantially Equivalent |
| K870279 | VP2000 INFUSION PUMP | Mar 25, 1987 | Substantially Equivalent |
| K854598 | VICKERS MEDICAL MODEL 272 TEMPERATURE MONITOR | Apr 7, 1986 | Substantially Equivalent |
| K854599 | VICKERS MEDICAL MODEL 273 OXYGEN MONITOR | Nov 27, 1985 | Substantially Equivalent |