FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
Vitalograph Model 6600 Compact
K Number: K142642
·
Decision Jun 30, 2015
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
227
Applicant Total
7
Review Days
286
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Basic Information
- Device Name
- Vitalograph Model 6600 Compact
- K Number
- K142642
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1840
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vitalograph (Ireland) , Ltd.
- Date Received
- September 17, 2014
- Decision Date
- June 30, 2015
- 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 Vitalograph (Ireland) , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K160253 | Vitalograph Model 6300 micro | Aug 26, 2016 | Substantially Equivalent |
| K142812 | Vitalograph Model 6800 Pneumotrac | Jun 29, 2015 | Substantially Equivalent |
| K141546 | VITALOGRAPH MODEL 7000 SPIROTRAC | Sep 3, 2014 | Substantially Equivalent |
| K110525 | VITALOGRAPH MODEL 7100 - VITALOJAK | Nov 23, 2011 | Substantially Equivalent |
| K100687 | VITALOGRAPH HAND HELD SPIROMETER, MODEL 2120 | Oct 16, 2010 | Substantially Equivalent |
| K073155 | VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6) | Jun 4, 2008 | Substantially Equivalent |