FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ESOPHAGEAL STETHOSCOPES
K Number: K843070
·
Decision Aug 24, 1984
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
12
Applicant Total
14
Review Days
18
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Basic Information
- Device Name
- ESOPHAGEAL STETHOSCOPES
- K Number
- K843070
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.1910
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Primrose Medical, Inc.
- Date Received
- August 6, 1984
- Decision Date
- August 24, 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
QUAZAR ESOPHAGEAL STETHOSCOPE
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 Primrose Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K884714 | BILIARY DIALATOR | Sep 29, 1989 | Substantially Equivalent |
| K884715 | ACHELASIA BALLOON DIALATOR | Sep 29, 1989 | Substantially Equivalent |
| K884713 | COLONIC BALLOON DIALATORS | Sep 29, 1989 | Substantially Equivalent |
| K884711 | URETHRAL AND URETERAL BALLOON DILATATORS | Sep 29, 1989 | Substantially Equivalent |
| K884709 | ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL) | Sep 8, 1989 | Substantially Equivalent |
| K884712 | ESOPHAGEAL AND PYLORIC BALLOON DIALATORS | Sep 8, 1989 | Substantially Equivalent |
| K883420 | LANCET, BLOOD | Aug 26, 1988 | Substantially Equivalent |
| K881976 | CATHETER, INTRAVASCULAR | Aug 4, 1988 | Substantially Equivalent |
| K881977 | PRESSURE INFUSOR | Jul 29, 1988 | Substantially Equivalent |
| K881975 | SET, INTRAVASCULAR | Jul 29, 1988 | Substantially Equivalent |