FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARE TELSTAT MODELS: MP 5010 AND MP 5020
K Number: K874844
·
Decision Feb 9, 1988
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
338
Applicant Total
3
Review Days
77
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CARE TELSTAT MODELS: MP 5010 AND MP 5020
- K Number
- K874844
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Care Systems, Inc.
- Date Received
- November 24, 1987
- Decision Date
- February 9, 1988
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DRT), ordered by most recent decision date.
The Circadia C300 System (C300)
FDA 510(k)
FDA Class 2
·Cardiovascular
The Circadia C300 System (C300)
FDA 510(k)
FDA Class 2
·Cardiovascular
Sleepiz One+ (Model 2.5)
FDA 510(k)
FDA Class 2
·Cardiovascular
Sleepiz One+ (2.5)
FDA 510(k)
FDA Class 2
·Cardiovascular
The Circadia C200 System
FDA 510(k)
FDA Class 2
·Cardiovascular
Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software
FDA 510(k)
FDA Class 2
·Cardiovascular