FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MILLENNIA 3500 SERIES MONITOR WITH ANTHESTHETIC AGENT
K Number: K974581
·
Decision Oct 28, 1998
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
338
Applicant Total
14
Review Days
324
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Basic Information
- Device Name
- MILLENNIA 3500 SERIES MONITOR WITH ANTHESTHETIC AGENT
- K Number
- K974581
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Invivo Research, Inc.
- Date Received
- December 8, 1997
- Decision Date
- October 28, 1998
- 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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