FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
QUAZAR ESOPHAGEAL STETHOSCOPE
K Number: K841574
·
Decision Aug 15, 1984
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
12
Applicant Total
28
Review Days
120
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
- QUAZAR ESOPHAGEAL STETHOSCOPE
- K Number
- K841574
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.1910
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Axiom Medical, Inc.
- Date Received
- April 17, 1984
- Decision Date
- August 15, 1984
- Product Code
- BZW
- 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 |
|---|---|---|---|
| BZW | Stethoscope, Esophageal | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BZW), ordered by most recent decision date.
MODIFIED ESOPHAGEAL STETHOSCOPE/TEMPERATURE SENSOR
FDA 510(k)
FDA Class 1
·Anesthesiology
ESOPHAGEAL STETHOSCOPE
FDA 510(k)
FDA Class 1
·Anesthesiology
ESOPHAGEAL STETHOSCOPE
FDA 510(k)
FDA Class 1
·Anesthesiology
ESOPHAGEAL STETHOSCOPES
FDA 510(k)
FDA Class 1
·Anesthesiology
ESOPHAGEAL STETHOSCOPE
FDA 510(k)
FDA Class 1
·Anesthesiology
ESOPHAGEAL STETHOSCOPE
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by Axiom Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K993592 | AXIOM MULTIPURPOSE WOUND DRAIN | May 17, 2000 | Substantially Equivalent |
| K971851 | INTERPLEURAL ANESTHESIA CATHETER | Jan 22, 1998 | Substantially Equivalent |
| K965146 | FLAT CLOSED WOUND DRAIN WITH TROCAR | Mar 10, 1997 | Substantially Equivalent |
| K934895 | GLASSMAN SILICONE CATHETER | Oct 13, 1994 | Substantially Equivalent |
| K922760 | ATRAUM WOUND DRESSING--MODIFICATION | Oct 30, 1992 | Substantially Equivalent |
| K905422 | PVC ROUND WOUND DRAINS | Feb 11, 1991 | Substantially Equivalent |
| K904218 | SUCTION SYSTEM | Oct 31, 1990 | Substantially Equivalent |
| K904133 | DISPOSABLE FLUID COLLECTION BAG | Oct 11, 1990 | Substantially Equivalent |
| K863247 | AXIOM TROCAR THORACIC CATHETER | Aug 29, 1986 | Substantially Equivalent |
| K861306 | SUCTION SYSTEM | Jun 9, 1986 | Substantially Equivalent |