FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PATIENT MONITOR 575
K Number: K830433
·
Decision Mar 24, 1983
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
338
Applicant Total
12
Review Days
43
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Basic Information
- Device Name
- PATIENT MONITOR 575
- K Number
- K830433
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Kone Instruments, Inc.
- Date Received
- February 9, 1983
- Decision Date
- March 24, 1983
- 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 Kone Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K873345 | 'MICROLYTE 4/5' | Sep 11, 1987 | Substantially Equivalent |
| K870777 | PROGRESS PLUS SELECTIVE CHEMISTRY ANALYZER | Mar 13, 1987 | Substantially Equivalent |
| K863466 | M700 STRESS MONITOR | Dec 22, 1986 | Substantially Equivalent |
| K862655 | SIGNA II RESTING ECG ELECTRODE | Aug 6, 1986 | Substantially Equivalent |
| K860767 | MODEL E 600 ELECTROCARDIOGRAPH | Apr 23, 1986 | Substantially Equivalent |
| K853354 | MEDIC 4 | Oct 11, 1985 | Substantially Equivalent |
| K840200 | PROGRESS SELECTIVE DHEMISTRY ANALYZ | Apr 4, 1984 | Substantially Equivalent |
| K830432 | CENTRAL STATION 590 | Mar 24, 1983 | Substantially Equivalent |
| K822952 | 560 | Nov 1, 1982 | Substantially Equivalent |
| K820541 | MICROLYTE | May 24, 1982 | Substantially Equivalent |