FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EMS PULMONARY FUNCTION TESTING FILTER
K Number: K013123
·
Decision Mar 14, 2002
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
227
Applicant Total
22
Review Days
176
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Basic Information
- Device Name
- EMS PULMONARY FUNCTION TESTING FILTER
- K Number
- K013123
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1840
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Engineered Medical Systems
- Date Received
- September 19, 2001
- Decision Date
- March 14, 2002
- 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 Engineered Medical Systems
| K Number | Device Name | ||
|---|---|---|---|
| K023683 | MULTI-STRAP FULL FACE MASK | Dec 1, 2003 | Substantially Equivalent |
| K013728 | TRACH VOX | Jul 30, 2002 | Substantially Equivalent |
| K013122 | EMS ELECTROSTATIC FLITER AND HME COMBINATION | Apr 19, 2002 | Substantially Equivalent |
| K013089 | EMS HEPA FILTER AND HME COMBINATIONS | Mar 14, 2002 | Substantially Equivalent |
| K003497 | DISPOSABLE PRESSURE MONITOR | Nov 30, 2000 | Substantially Equivalent |
| K000215 | SWIVEL ELBOW | May 26, 2000 | Substantially Equivalent |
| K000314 | INCENTIVE SPIROMETER | Apr 12, 2000 | Substantially Equivalent |
| K991955 | MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION | Jul 6, 1999 | Substantially Equivalent |
| K991953 | MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION | Jul 1, 1999 | Substantially Equivalent |
| K983919 | EMS MOUTH TO MASK RESUSCITATORS | Apr 7, 1999 | Substantially Equivalent |