FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COMFIT
K Number: K834089
·
Decision Dec 29, 1983
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
18
Applicant Total
42
Review Days
31
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Basic Information
- Device Name
- COMFIT
- K Number
- K834089
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5280
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Ackrad Laboratories
- Date Received
- November 28, 1983
- Decision Date
- December 29, 1983
- Product Code
- JAY
- 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 |
|---|---|---|---|
| JAY | Support, Breathing Tube | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JAY), ordered by most recent decision date.
CUSTOM MEDICAL SUSPENSION STRAP
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BLOCK, BITE, INTUBATION
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DALE HEAD BAND ANESTHESIA CIRCUIT TUBE HOLDER 1315
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JEE FRAME (VENTILATOR CIRCUIT SUPPORT)
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COMFIT PLUS ENDOTRACHEAL TUBE HOLDER & BITE BLOCK
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FDA Class 1
·Anesthesiology
ENDO-SECURE
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by Ackrad Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K021272 | SIB CATHETER, MODEL 61-7005 | May 21, 2002 | Substantially Equivalent |
| K020954 | H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAY | Apr 24, 2002 | Substantially Equivalent |
| K020951 | H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007 | Apr 16, 2002 | Substantially Equivalent |
| K970492 | INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER | Apr 9, 1997 | Substantially Equivalent |
| K961752 | H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607) | Aug 8, 1996 | Substantially Equivalent |
| K940176 | ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION | Apr 23, 1996 | Substantially Equivalent |
| K952542 | ACKRAD ESOPHAGEAL BALLOON CATHETER SET | Apr 23, 1996 | Substantially Equivalent |
| K953034 | H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607) | Aug 29, 1995 | Substantially Equivalent |
| K915813 | ACKRAD ERCP CONTRAST DELIVERY SET | Mar 11, 1992 | Substantially Equivalent |
| K904499 | NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM) | Jul 1, 1991 | Substantially Equivalent |