FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
K3 SYSTEM
K Number: K934644
·
Decision Nov 1, 1994
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
338
Applicant Total
13
Review Days
398
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Basic Information
- Device Name
- K3 SYSTEM
- K Number
- K934644
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Astro-Med, Inc.
- Date Received
- September 29, 1993
- Decision Date
- November 1, 1994
- 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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