FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
BIOLOGICAL SOUND MONITOR (BSM) SENSOR
K Number: K021389
·
Decision Oct 1, 2002
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
153
Applicant Total
5
Review Days
152
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Basic Information
- Device Name
- BIOLOGICAL SOUND MONITOR (BSM) SENSOR
- K Number
- K021389
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 870.1875
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Andromed, Inc.
- Date Received
- May 2, 2002
- Decision Date
- October 1, 2002
- Product Code
- DQD
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DQD | Stethoscope, Electronic | FDA class 2 | Cardiovascular |
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Other Clearances by Andromed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K051779 | ANDROFLOW - RESPIRATORY RATE MONITOR | Sep 30, 2005 | Substantially Equivalent |
| K022298 | I-STETHOS LINK | Oct 1, 2002 | Substantially Equivalent |
| K010729 | AGILENT ELECTRONIC STETHOSCOPE, MODELS M4532A AND M4533A | Oct 26, 2001 | Substantially Equivalent |
| K001306 | STETHOS, MODEL STXXYYZZ OR 001 XXX, STETHOS LINK, MODEL SLXXYYZZ OR 002 XXX | Jul 20, 2000 | Substantially Equivalent |