FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEART - AID ALS, 95
K Number: K841556
·
Decision Jul 19, 1984
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
2
Applicant Total
17
Review Days
94
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Basic Information
- Device Name
- HEART - AID ALS, 95
- K Number
- K841556
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3900
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Cardiac Resucitator Corp.
- Date Received
- April 16, 1984
- Decision Date
- July 19, 1984
- Product Code
- LDO
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| LDO | Enzymatic Radiochemical Assay, Tobramycin | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LDO), ordered by most recent decision date.
VITROS CHEMISTRY PRODUCTS TOBRA REAGENT, CALIBRATOR KIT 14 AND TDM PERFORMANCE VERIFIERS I, II AND III
FDA 510(k)
FDA Class 2
·Clinical Toxicology
EMIT ASSAY AND TOBRAMYCIN
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Other Clearances by Cardiac Resucitator Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K882513 | MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR | Jul 12, 1988 | Substantially Equivalent |
| K871971 | MODIFIED PACE*AID MODEL 53 | Jun 24, 1987 | Substantially Equivalent |
| K871538 | STAT-PAD (TM) | Jun 24, 1987 | Substantially Equivalent |
| K871569 | MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR | Jun 8, 1987 | Substantially Equivalent |
| K870622 | HEART*AID 1000 | Apr 10, 1987 | Substantially Equivalent |
| K850596 | PACE*AID 10 A -PAD 10A- PACEMAKER OUTPUT DISPLAY & | Mar 6, 1985 | Substantially Equivalent |
| K850170 | HEART AID MODEL 97 | Feb 14, 1985 | Substantially Equivalent |
| K844811 | PACE AID MODEL 53 | Jan 24, 1985 | Substantially Equivalent |
| K843547 | PACE *AID MODEL 52 | Dec 17, 1984 | Substantially Equivalent |
| K843358 | HEART-AID MODEL 80 | Nov 19, 1984 | Substantially Equivalent |