FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FOX POST NASAL BALLOON CATHETER
K Number: K841040
·
Decision Aug 17, 1984
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
46
Applicant Total
32
Review Days
158
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Basic Information
- Device Name
- FOX POST NASAL BALLOON CATHETER
- K Number
- K841040
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4100
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Inmed Corp.
- Date Received
- March 12, 1984
- Decision Date
- August 17, 1984
- Product Code
- EMX
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| EMX | Balloon, Epistaxis | FDA class 1 | Ear, Nose, Throat |
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Other Clearances by Inmed Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K862672 | ESOPHAGEAL STETHOSCOPE WITH THERMISTOR | Oct 27, 1986 | Substantially Equivalent |
| K853162 | STERILE NASOPHARYNGEAL AIRWAY | Aug 6, 1985 | Substantially Equivalent |
| K850152 | PRECONNECTED URETHRAL CATHETER TRAY | Mar 12, 1985 | Substantially Equivalent |
| K850335 | URETEROSCOPY CATHETER | Mar 12, 1985 | Substantially Equivalent |
| K850248 | DISPOSABLE GUEDEL AIRWAY | Mar 12, 1985 | Substantially Equivalent |
| K844801 | ULTRA EXTERNAL CATHETER | Jan 15, 1985 | Substantially Equivalent |
| K842301 | DISPOSABLE LATEX BANDAGE | Nov 5, 1984 | Substantially Equivalent |
| K842866 | URETHRAL CATHETERIZATION TRAY | Sep 10, 1984 | Substantially Equivalent |
| K842865 | ESOPHAGEAL STETHOSCOPE | Aug 15, 1984 | Substantially Equivalent |
| K841037 | PENROSE DRAINS | Apr 25, 1984 | Substantially Equivalent |