FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ESOPHAGEAL STETHOSCOPE
K Number: K830329
·
Decision Mar 11, 1983
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
12
Applicant Total
9
Review Days
38
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Basic Information
- Device Name
- ESOPHAGEAL STETHOSCOPE
- K Number
- K830329
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.1910
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Science Development Corp.
- Date Received
- February 1, 1983
- Decision Date
- March 11, 1983
- 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)
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·Anesthesiology
ESOPHAGEAL STETHOSCOPE
FDA 510(k)
FDA Class 1
·Anesthesiology
ESOPHAGEAL STETHOSCOPE
FDA 510(k)
FDA Class 1
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ESOPHAGEAL STETHOSCOPES
FDA 510(k)
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·Anesthesiology
QUAZAR ESOPHAGEAL STETHOSCOPE
FDA 510(k)
FDA Class 1
·Anesthesiology
ESOPHAGEAL STETHOSCOPE
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by Science Development Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K843617 | SDC SILICONE SUMP DRAIN | Oct 24, 1984 | Substantially Equivalent |
| K842491 | SDC SILICONE FORCEP SHODS PRODUCT | Aug 10, 1984 | Substantially Equivalent |
| K833355 | SDC VASCULAR TIES | Jan 27, 1984 | Substantially Equivalent |
| K832090 | SCD SKIN TEMP. SENSORS #3400 ETC | Oct 31, 1983 | Substantially Equivalent |
| K832391 | QT-100 ELECTRONIC TEMP. MONITOR | Sep 12, 1983 | Substantially Equivalent |
| K832392 | SDC ORAL-RECTAL TEMP. PROBE | Sep 12, 1983 | Substantially Equivalent |
| K830353 | ESOPHAGEAL PROBE W/TEMP. INDICATOR | Apr 6, 1983 | Substantially Equivalent |
| K830039 | SDC RECTAL TEMP. PROBE PRODUCT #1020 | Feb 23, 1983 | Substantially Equivalent |