FDA 510(k)
FDA class 1
Unknown
🇺🇸 United States
MEDCARE TRACHEOSTOMY CARE TRAY
K Number: K961167
·
Decision Jul 2, 1996
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
5
Applicant Total
8
Review Days
99
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Basic Information
- Device Name
- MEDCARE TRACHEOSTOMY CARE TRAY
- K Number
- K961167
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Medcare Medical Group, Inc.
- Date Received
- March 25, 1996
- Decision Date
- July 2, 1996
- Product Code
- LRQ
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| LRQ | Tracheostomy And Nasal Suctioning Kit | FDA class 1 | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LRQ), ordered by most recent decision date.
TRACHEOSTOMY KIT
FDA 510(k)
FDA Class 1
·Unknown
READY NURSE SYSTEM (RNS) TRACH CARE KIT
FDA 510(k)
FDA Class 1
·Unknown
GENT-L-KARE TRACHEOSTOMY TRAYS
FDA 510(k)
FDA Class 1
·Unknown
TRACHEOSTOMY & NASAL SUCTIONING KIT, 3C-TNS-1
FDA 510(k)
FDA Class 1
·Unknown
TRACHEOSTOMY CARE TRAY
FDA 510(k)
FDA Class 1
·Unknown
Other Clearances by Medcare Medical Group, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K973497 | HUBERLOC | Jan 13, 1998 | Substantially Equivalent |
| K970152 | BIOPSY TRAY | Mar 5, 1997 | Substantially Equivalent for Some Indications |
| K962849 | CATHETER INSERTION TRAY | Oct 7, 1996 | Substantially Equivalent |
| K961075 | MEDCARE REGIONAL ANETHESIA KIT | Sep 6, 1996 | Unknown |
| K962328 | SINGLE USE INSTRUMENT TRAY | Aug 9, 1996 | Substantially Equivalent |
| K962527 | GENERAL PURPOSE DENTAL TRAY | Aug 1, 1996 | Substantially Equivalent |
| K961880 | MEDCARE SUCTION CONNECTING TUBING | Jul 19, 1996 | Substantially Equivalent |