FDA 510(k)
Substantially Equivalent
🇺🇸 United States
ACU-ALERT
K Number: K791399
·
Decision Oct 11, 1979
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
8
Review Days
87
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Basic Information
- Device Name
- ACU-ALERT
- K Number
- K791399
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Acumed Instruments Corp.
- Date Received
- July 16, 1979
- Decision Date
- October 11, 1979
- Advisory Committee
- Unknown
- Review Advisory Committee
- CV
- Third Party
- N
Other Clearances by Acumed Instruments Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K863627 | MICRO SURGICAL DRILL SYSTEM | Oct 2, 1986 | Substantially Equivalent |
| K853660 | MICRO SURGICAL DRILL SYSTEM | Sep 24, 1985 | Substantially Equivalent |
| K853658 | BURS FOR MICRO SURGICAL DRILL SYSTEM | Sep 24, 1985 | Substantially Equivalent |
| K853659 | POWERED IRRIGATION FOR MICRO SURGICAL DRILL | Sep 24, 1985 | Substantially Equivalent |
| K791891 | ACU-MED RED MISER HEMOTHORAX BLOOD COLL. | Dec 5, 1979 | Substantially Equivalent |
| K791400 | GASTRIC LAVAGE KIT-DISPOSABLE | Aug 16, 1979 | Substantially Equivalent |
| K790901 | I.V. TUBING ORGANIZER | Jun 27, 1979 | Substantially Equivalent |