FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEART RATE VARIABILITY SOFTWARE OPTION
K Number: K950779
·
Decision Apr 25, 1995
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
574
Applicant Total
46
Review Days
63
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Basic Information
- Device Name
- HEART RATE VARIABILITY SOFTWARE OPTION
- K Number
- K950779
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Spacelabs, Inc.
- Date Received
- February 21, 1995
- Decision Date
- April 25, 1995
- Product Code
- DPS
- 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 |
|---|---|---|---|
| DPS | Electrocardiograph | FDA class 2 | Cardiovascular |
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Other Clearances by Spacelabs, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K954962 | SPACELABS MEDICAL MULTIGAS ANALYZER | May 31, 1996 | Substantially Equivalent |
| K951605 | SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEM | Jul 14, 1995 | Substantially Equivalent |
| K941165 | COMET CAPNOGRAPH MODULE | Oct 6, 1994 | Substantially Equivalent |
| K923788 | SPACE LABS MODEL 90560 | Dec 6, 1993 | Substantially Equivalent |
| K912742 | ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE | Apr 20, 1992 | Substantially Equivalent |
| K913038 | SPACELAB MODEL 90845 PCMS MULTIDISCLOSURE STATION | Oct 4, 1991 | Substantially Equivalent |
| K905065 | DEFIBRILLATOR LEAD ADAPTER | Apr 12, 1991 | Substantially Equivalent |
| K910029 | PATIENT CARE MANAGEMENT SYSTEM MODIFICATION | Jan 31, 1991 | Substantially Equivalent |
| K896903 | FIRST MEDIC MODEL 510 | Dec 27, 1990 | Substantially Equivalent |
| K904318 | LOCAL REPORT GENERATOR | Dec 18, 1990 | Substantially Equivalent |