Hortmann Airmatic Air Caloric Stimulator
FDA 510(k) K950785 · Jedmed Instrument Co.
510(k) numberK950785
Submission
- Device name
- Hortmann Airmatic Air Caloric Stimulator
- Applicant
- Jedmed Instrument Co.
St.Louis, MO, US - Received
- February 21, 1995
- Decision date
- June 28, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KHH – Stimulator, Caloric-Air
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.1800
- Specialty
- Ear, Nose, Throat
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|---|---|---|---|
| K946108 | Ear-A-GatorKHH · Traditional | Life-Tech Intl., Inc. | 06/13/1995SE |
| K941325 | Water Irrigator, W1 200KHH · Traditional | Strong Medical, Inc. | 08/09/1994SE |
| K931608 | NCA-200KHH · Traditional | Ics Medical Corp. | 06/22/1993SE |
| K925237 | Automatic Caloric Irrigation SystemKHH · Traditional | Ics Medical Corp. | 05/05/1993SE |
| K881630 | Automatic Caloric Irrigation SystemKHH · Traditional | Ics Medical Corp. | 06/21/1988SE |
| K822179 | Frenzel Eyeglasses & Related ItemsKHH · Traditional | Kelleher Corp. | 09/21/1982SE |
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| K950925 | Jedmed Laryngeal ScopeEOQ · Traditional | 08/11/1995SE |
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Questions and answers
When was Hortmann Airmatic Air Caloric Stimulator cleared by the FDA?
Hortmann Airmatic Air Caloric Stimulator (K950785) received a 510(k) decision of Substantially Equivalent on June 28, 1995, 127 days after the submission was received.
What is the product code of K950785?
The FDA product code is KHH – Stimulator, Caloric-Air, a Class I (low risk) device regulated under 21 CFR 874.1800.