FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BECHLER MEDICAL, MODEL 5000,THE WIZ HOLTER SCANNER
K Number: K861240
·
Decision May 2, 1986
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
397
Applicant Total
2
Review Days
30
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Basic Information
- Device Name
- BECHLER MEDICAL, MODEL 5000,THE WIZ HOLTER SCANNER
- K Number
- K861240
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Mountain View Medical
- Date Received
- April 2, 1986
- Decision Date
- May 2, 1986
- Product Code
- DSI
- 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 |
|---|---|---|---|
| DSI | Detector And Alarm, Arrhythmia | FDA class 2 | Cardiovascular |
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Other Clearances by Mountain View Medical
| K Number | Device Name | ||
|---|---|---|---|
| K853985 | MVM 4000 HOLTER IV RECORDER | Nov 6, 1985 | Substantially Equivalent |