FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TRACH-EZE
K Number: K903740
·
Decision Dec 6, 1990
Classifications
1
FEI Numbers
245
Registration Numbers
245
Same Product Code
115
Applicant Total
9
Review Days
112
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Basic Information
- Device Name
- TRACH-EZE
- K Number
- K903740
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.6810
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Sorex Medical
- Date Received
- August 16, 1990
- Decision Date
- December 6, 1990
- Product Code
- BSY
- 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 |
|---|---|---|---|
| BSY | Catheters, Suction, Tracheobronchial | FDA class 1 | Anesthesiology |
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Other Clearances by Sorex Medical
| K Number | Device Name | ||
|---|---|---|---|
| K923843 | FOGLESS | Mar 25, 1994 | Substantially Equivalent |
| K913036 | PLUME MASTER | Sep 6, 1991 | Substantially Equivalent |
| K911070 | PICC-FIX | Jul 5, 1991 | Substantially Equivalent |
| K911150 | SOREX SAFE-AIR | Jun 28, 1991 | Substantially Equivalent |
| K910315 | PICC INSERTION KIT/P.I.C. & PICC EXCHANG KIT/P.E.K | Apr 5, 1991 | Unknown |
| K905572 | EDLICH WOUND MANAGEMENT TRAY | Mar 12, 1991 | Unknown |
| K902410 | MEDICAL PROCEDURE TRAY | Nov 20, 1990 | Unknown |
| K885136 | GRAFT GUARD | Feb 6, 1989 | Substantially Equivalent |