FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOMECCA CENTRAL CS1
K Number: K854639
·
Decision Apr 17, 1986
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
338
Applicant Total
2
Review Days
149
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Basic Information
- Device Name
- BIOMECCA CENTRAL CS1
- K Number
- K854639
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Biomecca Australia , Ltd.
- Date Received
- November 19, 1985
- Decision Date
- April 17, 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 Biomecca Australia , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K860790 | BIOMECCA CARETAKER 1000 & 2000 | May 8, 1986 | Substantially Equivalent |