FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPIROTEL, MODEL 29-1020
K Number: K031643
·
Decision Dec 9, 2003
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
227
Applicant Total
10
Review Days
196
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Basic Information
- Device Name
- SPIROTEL, MODEL 29-1020
- K Number
- K031643
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1840
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sdi Diagnostics, Inc.
- Date Received
- May 27, 2003
- Decision Date
- December 9, 2003
- Product Code
- BZG
- 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 |
|---|---|---|---|
| BZG | Spirometer, Diagnostic | FDA class 2 | Anesthesiology |
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|---|---|---|---|
| K150515 | IQSense Flow Sensor Mouthpiece | Jan 12, 2016 | Substantially Equivalent |
| K092813 | ASTRASONIC SPIROMETER, MODEL 29-8000 | Jul 16, 2010 | Substantially Equivalent |
| K061571 | ASTRA 300 | Jan 31, 2007 | Substantially Equivalent |
| K062913 | ASTRAGUARD PULMONARY FUNCTION FILTER | Jan 26, 2007 | Substantially Equivalent |
| K033939 | FLOSENSE II, MODEL 29-8040 | Jan 30, 2004 | Substantially Equivalent |
| K013812 | SPIROLAB II, MODEL 29 | Feb 11, 2002 | Substantially Equivalent |
| K011470 | SDI SB OFFICE, MODEL 29- | Oct 12, 2001 | Substantially Equivalent |
| K990962 | FLOSENSE, MODEL 29-8010 | Jan 7, 2000 | Substantially Equivalent |
| K934509 | PULMOGUARD DISPOSABLE BATERIAL/VIRAL FILTER | Oct 21, 1993 | Substantially Equivalent |