FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BRENTWOOD IQMARK DIGITAL SPIROMETER (INCLUDES DISPOSABLE PNEUMOTACH MOUTHPIECES AND 3-LITER CALIBRATION SYRINGE
K Number: K002499
·
Decision Nov 8, 2000
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
227
Applicant Total
7
Review Days
86
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Basic Information
- Device Name
- BRENTWOOD IQMARK DIGITAL SPIROMETER (INCLUDES DISPOSABLE PNEUMOTACH MOUTHPIECES AND 3-LITER CALIBRATION SYRINGE
- K Number
- K002499
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1840
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Brentwood Medical Technology Corp.
- Date Received
- August 14, 2000
- Decision Date
- November 8, 2000
- 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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Other Clearances by Brentwood Medical Technology Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K103640 | MIDMARK IQECG | Mar 22, 2011 | Substantially Equivalent |
| K100913 | IQVITALS AND IQVITALS SYSTEM | May 26, 2010 | Substantially Equivalent |
| K052898 | IQMARK EZ STRESS | Mar 28, 2006 | Substantially Equivalent |
| K031466 | IQMARK DIGITAL HOLTER | Jun 11, 2003 | Substantially Equivalent |
| K013717 | BRENTWOOD REAL TIME ST AND ARRHYTHMIA ANALYSIS SOFTWARE LIBRARY | Feb 6, 2002 | Substantially Equivalent |
| K010505 | TELEMED 12 LEAD RESTING ECG ANALYSIS LIBRARY | Mar 9, 2001 | Substantially Equivalent |