FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TURBOAIRE CHALLANGER ENVIRONMENTAL AIR CONTROLLER
K Number: K843996
·
Decision Nov 20, 1984
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
227
Applicant Total
7
Review Days
40
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Basic Information
- Device Name
- TURBOAIRE CHALLANGER ENVIRONMENTAL AIR CONTROLLER
- K Number
- K843996
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1840
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Equilibrated Bio Systems, Inc.
- Date Received
- October 11, 1984
- Decision Date
- November 20, 1984
- Product Code
- BZG
- 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 |
|---|---|---|---|
| BZG | Spirometer, Diagnostic | FDA class 2 | Anesthesiology |
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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 |
| K791294 | SPIROCAL | Aug 16, 1979 | Substantially Equivalent |
| K790410 | ADULT ZEE-FRAME | Mar 22, 1979 | Substantially Equivalent |
| K781509 | ZEE-FRAME | Sep 26, 1978 | Substantially Equivalent |
| K781386 | EBS 775 TONOMETER | Sep 14, 1978 | Substantially Equivalent |