FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TELEMETRY SYSTEM, BIOTEL 300
K Number: K781836
·
Decision Dec 4, 1978
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
190
Applicant Total
46
Review Days
35
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
- TELEMETRY SYSTEM, BIOTEL 300
- K Number
- K781836
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2910
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Spacelabs, Inc.
- Date Received
- October 30, 1978
- Decision Date
- December 4, 1978
- Product Code
- DRG
- 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 |
|---|---|---|---|
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DRG), ordered by most recent decision date.
Perin Health System (PHD80060-2)
FDA 510(k)
FDA Class 2
·Cardiovascular
EasyTeleMed (2.0.2)
FDA 510(k)
FDA Class 2
·Cardiovascular
TeleRehab Aermos Cardiopulmonary Rehabilitation
FDA 510(k)
FDA Class 2
·Cardiovascular
iBSM
FDA 510(k)
FDA Class 2
·Cardiovascular
UbiqVue 2A Multi-parameter System (UX2550)
FDA 510(k)
FDA Class 2
·Cardiovascular
BioButton System
FDA 510(k)
FDA Class 2
·Cardiovascular
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 |
| K950779 | HEART RATE VARIABILITY SOFTWARE OPTION | Apr 25, 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 |