FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EBS 775 TONOMETER
K Number: K781386
·
Decision Sep 14, 1978
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
8
Applicant Total
7
Review Days
34
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Basic Information
- Device Name
- EBS 775 TONOMETER
- K Number
- K781386
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Equilibrated Bio Systems, Inc.
- Date Received
- August 11, 1978
- Decision Date
- September 14, 1978
- Product Code
- LCH
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| LCH | Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical | FDA class 1 | Clinical Chemistry |
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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 |
| K843996 | TURBOAIRE CHALLANGER ENVIRONMENTAL AIR CONTROLLER | Nov 20, 1984 | 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 |