510(k) K931608
- Device
- NCA-200
- Applicant
- ICS MEDICAL CORP.
- 510(k) number
- K931608
- Product code
- KHH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-06-22
- Date received
- 1993-04-01
- Regulation
- 874.1800
- Classification name
- Stimulator, Caloric-air
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- DELMAR F BLOEM
- Address
- 2227 Hammond Dr. Schaumburg IL US 60173 60173
FDA Registration Numbers#
- 3005581270
- 9710051
- 1836161
- 3011310592
- 9710334
- 8010573
- 9612197
- 3005527904
- 8030607
- 3034880867
- 8010257
- 3011522961
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KHH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K950785 | HORTMANN AIRMATIC AIR CALORIC STIMULATOR | Jedmed Instrument Co. | 1995-06-28 |
| K946108 | EAR-A-GATOR | Life-Tech Intl., Inc. | 1995-06-13 |
| K941325 | WATER IRRIGATOR, W1 200 | Strong Medical, Inc. | 1994-08-09 |
| K925237 | AUTOMATIC CALORIC IRRIGATION SYSTEM | Ics Medical Corp. | 1993-05-05 |
| K881630 | AUTOMATIC CALORIC IRRIGATION SYSTEM | Ics Medical Corp. | 1988-06-21 |
| K822179 | FRENZEL EYEGLASSES & RELATED ITEMS | Kelleher Corp. | 1982-09-21 |
Legacy Summary#
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FDA Review#
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