FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
507EL VITAL SIGNS MONITOR
K Number: K022435
·
Decision Aug 14, 2002
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
338
Applicant Total
22
Review Days
20
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
- 507EL VITAL SIGNS MONITOR
- K Number
- K022435
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Criticare Systems, Inc.
- Date Received
- July 25, 2002
- Decision Date
- August 14, 2002
- 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
Other Clearances by Criticare Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K101602 | VITAL SIGNS MONITOR | Sep 1, 2010 | Substantially Equivalent |
| K091050 | 506CN PATIENT MONITOR | May 27, 2009 | Substantially Equivalent |
| K042569 | 8600 VITAL SIGNS MONITOR | Sep 29, 2004 | Substantially Equivalent |
| K030613 | VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100 | Apr 17, 2003 | Substantially Equivalent |
| K012059 | 8100/8500 VITAL SIGNS MONITOR | Aug 1, 2001 | Substantially Equivalent |
| K001020 | 8100 VITAL SIGNS MONITOR | Apr 28, 2000 | Substantially Equivalent |
| K000276 | MPT 24 AND VITAL VIEW 24 | Mar 1, 2000 | Substantially Equivalent |
| K961223 | MULTIPLE PARAMETER TELEMETRY, VITAL VIEW, & MICROVIEW SYSTEMS | Dec 10, 1996 | Substantially Equivalent |
| K944860 | SCHOLAR PATIENT MONITOR | Jun 20, 1995 | Substantially Equivalent |
| K942737 | POET IQ WITH FIVE AGENT CAPABILITY | Feb 9, 1995 | Substantially Equivalent |