EMS Electrostatic Fliter and Hme Combination
FDA 510(k) K013122 · Engineered Medical Systems
510(k) numberK013122
Submission
- Device name
- EMS Electrostatic Fliter and Hme Combination
- Applicant
- Engineered Medical Systems
Mccordsville, IN, US - Received
- September 19, 2001
- Decision date
- April 19, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CAH – Filter, Bacterial, Breathing-Circuit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5260
- Specialty
- Anesthesiology
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| K210352 | GGM Breathing Circuit Bacterial FilterCAH · Traditional | Great Group Medical Co, Ltd. | 03/27/2022SE |
More from Great Group Medical Co, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K220533 | Endoscopy Oxygen MaskCCK · Traditional | 11/16/2022SE |
| K062104 | Talking TrachBTO · Traditional | 04/20/2007SE |
| K023683 | Multi-Strap Full Face MaskBZD · Traditional | 12/01/2003SE |
| K013728 | Trach VoxJOH · Traditional | 07/30/2002SE |
| K013123 | EMS Pulmonary Function Testing FilterBZG · Traditional | 03/14/2002SE |
| K013089 | EMS Hepa Filter and Hme CombinationsCAH · Traditional | 03/14/2002SE |
| K003497 | Disposable Pressure MonitorCAP · Traditional | 11/30/2000SE |
| K000215 | Swivel ElbowBZD · Traditional | 05/26/2000SE |
| K000314 | Incentive SpirometerBWF · Traditional | 04/12/2000SE |
| K991955 | Modification to Engineered Medical Systems Disposable Manual Resuscitator with CO2…BTM · Traditional | 07/06/1999SE |
Questions and answers
When was EMS Electrostatic Fliter and Hme Combination cleared by the FDA?
EMS Electrostatic Fliter and Hme Combination (K013122) received a 510(k) decision of Substantially Equivalent on April 19, 2002, 212 days after the submission was received.
What is the product code of K013122?
The FDA product code is CAH – Filter, Bacterial, Breathing-Circuit, a Class II (moderate risk) device regulated under 21 CFR 868.5260.