FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EMS MOUTH TO MASK RESUSCITATORS
K Number: K983919
·
Decision Apr 7, 1999
Classifications
1
FEI Numbers
70
Registration Numbers
70
Same Product Code
102
Applicant Total
22
Review Days
154
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Basic Information
- Device Name
- EMS MOUTH TO MASK RESUSCITATORS
- K Number
- K983919
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5870
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Engineered Medical Systems
- Date Received
- November 4, 1998
- Decision Date
- April 7, 1999
- Product Code
- CBP
- 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 |
|---|---|---|---|
| CBP | Valve, Non-Rebreathing | FDA class 2 | Anesthesiology |
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FDA Class 2
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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 |
| K013123 | EMS PULMONARY FUNCTION TESTING FILTER | 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 |