FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TELEMETRIC STETHOSCOPE
K Number: K882319
·
Decision Aug 2, 1988
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
44
Applicant Total
75
Review Days
57
Basic Information
- Device Name
- TELEMETRIC STETHOSCOPE
- K Number
- K882319
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1920
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- VITAL SIGNS, INC.
- Date Received
- June 6, 1988
- Decision Date
- August 2, 1988
- Product Code
- BZT
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BZT | Stethoscope, Esophageal, With Electrical Conductors | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BZT), ordered by most recent decision date.
Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French
FDA 510(k)
FDA Class 2
·Anesthesiology
ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR (NON-STERILE),ESOPHAGEAL STETHOSCOPE TEMPERATURE WITH ATTACHED EAR PIECE
FDA 510(k)
FDA Class 2
·Anesthesiology
ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FR
FDA 510(k)
FDA Class 2
·Anesthesiology
ESOPHAGEAL STETHOSCOPE
FDA 510(k)
FDA Class 2
·Anesthesiology
ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR
FDA 510(k)
FDA Class 2
·Anesthesiology
LIFESOUND ESOPHAGEAL STETHOSCOPE
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by VITAL SIGNS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K112902 | ENFLOW IV FLUID WARMER | Mar 14, 2012 | Substantially Equivalent |
| K041309 | IMASK TM | Jun 30, 2004 | Substantially Equivalent |
| K030985 | BREAS PV 10I CPAP SYSTEM, MODEL PV 10I | Oct 15, 2003 | Substantially Equivalent |
| K022402 | DISPOSABLE PRESSURE MANOMETER | Aug 22, 2002 | Substantially Equivalent |
| K021315 | SURE-LOK | Aug 21, 2002 | Substantially Equivalent |
| K002454 | BREAS HA50 HUMIDIFIER, MODEL HA50 | Mar 7, 2001 | Substantially Equivalent |
| K001553 | BREAS PV 100 CPAP SYSTEM | Aug 3, 2000 | Substantially Equivalent |
| K000441 | BODYGUARD | Apr 11, 2000 | Substantially Equivalent |
| K994044 | CLEEN-ABLE | Feb 25, 2000 | Substantially Equivalent |
| K990412 | CUFF-ABLE PLUS | Sep 1, 1999 | Substantially Equivalent |