FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLOSENSE, MODEL 29-8010
K Number: K990962
·
Decision Jan 7, 2000
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
7
Applicant Total
10
Review Days
291
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Basic Information
- Device Name
- FLOSENSE, MODEL 29-8010
- K Number
- K990962
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2550
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sdi Diagnostics, Inc.
- Date Received
- March 22, 1999
- Decision Date
- January 7, 2000
- Product Code
- JAX
- 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 |
|---|---|---|---|
| JAX | Pneumotachometer | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
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Other Clearances by Sdi Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K031643 | SPIROTEL, MODEL 29-1020 | Dec 9, 2003 | Substantially Equivalent |
| K013812 | SPIROLAB II, MODEL 29 | Feb 11, 2002 | Substantially Equivalent |
| K011470 | SDI SB OFFICE, MODEL 29- | Oct 12, 2001 | Substantially Equivalent |
| K934509 | PULMOGUARD DISPOSABLE BATERIAL/VIRAL FILTER | Oct 21, 1993 | Substantially Equivalent |