FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ESOPHAGEAL STETHOSCOPE
K Number: K842865
·
Decision Aug 15, 1984
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
12
Applicant Total
32
Review Days
23
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Basic Information
- Device Name
- ESOPHAGEAL STETHOSCOPE
- K Number
- K842865
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.1910
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Inmed Corp.
- Date Received
- July 23, 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
QUAZAR ESOPHAGEAL STETHOSCOPE
FDA 510(k)
FDA Class 1
·Anesthesiology
ESOPHAGEAL STETHOSCOPE
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by Inmed Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K862672 | ESOPHAGEAL STETHOSCOPE WITH THERMISTOR | Oct 27, 1986 | Substantially Equivalent |
| K853162 | STERILE NASOPHARYNGEAL AIRWAY | Aug 6, 1985 | Substantially Equivalent |
| K850152 | PRECONNECTED URETHRAL CATHETER TRAY | Mar 12, 1985 | Substantially Equivalent |
| K850335 | URETEROSCOPY CATHETER | Mar 12, 1985 | Substantially Equivalent |
| K850248 | DISPOSABLE GUEDEL AIRWAY | Mar 12, 1985 | Substantially Equivalent |
| K844801 | ULTRA EXTERNAL CATHETER | Jan 15, 1985 | Substantially Equivalent |
| K842301 | DISPOSABLE LATEX BANDAGE | Nov 5, 1984 | Substantially Equivalent |
| K842866 | URETHRAL CATHETERIZATION TRAY | Sep 10, 1984 | Substantially Equivalent |
| K841040 | FOX POST NASAL BALLOON CATHETER | Aug 17, 1984 | Substantially Equivalent |
| K841037 | PENROSE DRAINS | Apr 25, 1984 | Substantially Equivalent |