FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ADULT ZEE-FRAME
K Number: K790410
·
Decision Mar 22, 1979
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
18
Applicant Total
7
Review Days
24
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Basic Information
- Device Name
- ADULT ZEE-FRAME
- K Number
- K790410
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5280
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Equilibrated Bio Systems, Inc.
- Date Received
- February 26, 1979
- Decision Date
- March 22, 1979
- 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
FDA 510(k)
FDA Class 1
·Anesthesiology
ENDO-SECURE
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by Equilibrated Bio Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K892705 | EBS2605 INFANT HUGGER | Oct 27, 1989 | Substantially Equivalent |
| K855102 | MONARK 869 ERGOMETER | May 9, 1986 | Substantially Equivalent |
| K843996 | TURBOAIRE CHALLANGER ENVIRONMENTAL AIR CONTROLLER | Nov 20, 1984 | Substantially Equivalent |
| K791294 | SPIROCAL | Aug 16, 1979 | Substantially Equivalent |
| K781509 | ZEE-FRAME | Sep 26, 1978 | Substantially Equivalent |
| K781386 | EBS 775 TONOMETER | Sep 14, 1978 | Substantially Equivalent |