FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MATRX, PYRAMID TRIANGLE BANDAGE
K Number: K912661
·
Decision Aug 21, 1991
Classifications
1
FEI Numbers
326
Registration Numbers
326
Same Product Code
20
Applicant Total
14
Review Days
64
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Basic Information
- Device Name
- MATRX, PYRAMID TRIANGLE BANDAGE
- K Number
- K912661
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3640
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Matrix Medica, Inc.
- Date Received
- June 18, 1991
- Decision Date
- August 21, 1991
- Product Code
- ILI
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| ILI | Sling, Arm | FDA class 1 | Physical Medicine |
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Other Clearances by Matrix Medica, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K961536 | FLEXSCOPE | Sep 18, 1996 | Substantially Equivalent |
| K923693 | KLORMAN | Jan 23, 1996 | Substantially Equivalent |
| K921982 | MATRX HOPE(R) 5 RESUSCITATOR | Oct 28, 1994 | Substantially Equivalent |
| K915353 | MATRX MEDICAL MAXIMIZER 1000 AND 2000 VACUUM PUMP | Dec 27, 1991 | Substantially Equivalent |
| K900551 | MATRX DISPOSABLE NON-INVASIVE GELLED PACING ELEC. | May 9, 1990 | Substantially Equivalent |
| K895533 | LIFE DEFENSE PLUS(TM), DEFIBRILLATOR/MONITOR/PACER | Jan 26, 1990 | Substantially Equivalent |
| K895525 | MATRX BATTERY CHARGER/DEFIBRILLATOR TESTER | Jan 26, 1990 | Substantially Equivalent |
| K893219 | MATRX DENTAL UNIT | Aug 7, 1989 | Substantially Equivalent |
| K883833 | NITRONOX(R), FIRST RESPONSE NITRONOX(TM) | Feb 17, 1989 | Substantially Equivalent |
| K884879 | CENTURION(TM) MIXER | Feb 9, 1989 | Substantially Equivalent |