Microflow Irrigation System
FDA 510(k) K950078 · Jedmed Instrument Co.
510(k) numberK950078
Submission
- Device name
- Microflow Irrigation System
- Applicant
- Jedmed Instrument Co.
St.Louis, MO, US - Received
- January 10, 1995
- Decision date
- June 21, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KMA – Irrigator, Powered Nasal
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.5550
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code KMA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K140542 | Navage Nasal Irrigator, Navage Nose CleanerKMA · Traditional | Rhinosystems, Inc. | 06/27/2014SE |
| K973875 | Rinoflow Micronized E.N.T. Wash SystemKMA · Traditional | Respironics, Inc. | 01/26/1998SE |
| K963550 | Rinoflow Micronized E.N..T. Wash SytstemKMA · Traditional | Respironics, Inc. | 11/01/1996SE |
| K822351 | Powder BlowersKMA · Traditional | Kelleher Corp. | 09/14/1982SE |
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| K021750 | Lid Chain Eyelid WeightsMML · Traditional | 01/27/2003SE |
| K954184 | Jed-Light Fiberoptic Light SourceEQH · Traditional | 11/13/1995SE |
| K944032 | Video Scope System (Laryngoscope)ENZ · Traditional | 09/15/1995SE |
| K953457 | Jedmed Spectrum ENT CabinetETF · Traditional | 08/11/1995SE |
| K950925 | Jedmed Laryngeal ScopeEOQ · Traditional | 08/11/1995SE |
| K950785 | Hortmann Airmatic Air Caloric StimulatorKHH · Traditional | 06/28/1995SE |
| K944671 | Video Scope System (Nasopharyngoscope {Flexible or Rigid})EOB · Traditional | 02/07/1995SE |
| K944031 | Video Scope System (Otoscope)ERA · Traditional | 09/23/1994SE |
Questions and answers
When was Microflow Irrigation System cleared by the FDA?
Microflow Irrigation System (K950078) received a 510(k) decision of Substantially Equivalent on June 21, 1995, 162 days after the submission was received.
What is the product code of K950078?
The FDA product code is KMA – Irrigator, Powered Nasal, a Class I (low risk) device regulated under 21 CFR 874.5550.