FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
PULSE TIME PRODUCTS LIMITED, PM-3
K Number: K892795
·
Decision Aug 25, 1989
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
338
Applicant Total
6
Review Days
130
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Basic Information
- Device Name
- PULSE TIME PRODUCTS LIMITED, PM-3
- K Number
- K892795
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Pulse Time Products, Ltd.
- Date Received
- April 17, 1989
- Decision Date
- August 25, 1989
- 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 Pulse Time Products, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K901392 | BP50 BLOOD PRESSURE AND PULSE MONITOR | Aug 23, 1990 | Substantially Equivalent |
| K892794 | PULSE TIME PRODUCTS LIMITED, PM-2 | Aug 25, 1989 | Substantially Equivalent |
| K864411 | PULSE/B.P. MONITOR | Jun 24, 1987 | Substantially Equivalent |
| K864748 | PM-8 HEART RATE MONITOR | Mar 20, 1987 | Substantially Equivalent |
| K811425 | CARDIACMONITORS | Sep 16, 1981 | Substantially Equivalent |