FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROMENADE
K Number: K930947
·
Decision Jun 1, 1993
Classifications
1
FEI Numbers
189
Registration Numbers
189
Same Product Code
507
Applicant Total
8
Review Days
98
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Basic Information
- Device Name
- PROMENADE
- K Number
- K930947
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5630
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mada Medical Products, Inc.
- Date Received
- February 23, 1993
- Decision Date
- June 1, 1993
- Product Code
- CAF
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | FDA class 2 | Anesthesiology |
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Other Clearances by Mada Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K003862 | MADA WHEELCHAIRS | Jan 12, 2001 | Substantially Equivalent |
| K002943 | WHEELCHAIR, MECHANICAL SERIES MODEL 3100 | Oct 23, 2000 | Substantially Equivalent |
| K950777 | OXYGEN REGULATOR | Apr 14, 1995 | Substantially Equivalent |
| K930949 | VOYAGE | Jun 1, 1993 | Substantially Equivalent |
| K921611 | MADAVAC 190 | Sep 9, 1992 | Substantially Equivalent |
| K850754 | MEDAJET XL - JET INJECTOR | Dec 10, 1985 | Substantially Equivalent |
| K802426 | RESPO2 OXYGEN CONCENTRATOR | Oct 23, 1980 | Substantially Equivalent |