FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VACUSOL PLUS DENTAL VACUUM LINE CLEANER/DISINFECTANT
K Number: K934014
·
Decision Dec 6, 1995
Classifications
1
FEI Numbers
370
Registration Numbers
370
Same Product Code
72
Applicant Total
46
Review Days
841
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- VACUSOL PLUS DENTAL VACUUM LINE CLEANER/DISINFECTANT
- K Number
- K934014
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6890
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biotrol, USA, Inc.
- Date Received
- August 17, 1993
- Decision Date
- December 6, 1995
- Product Code
- LRJ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| LRJ | Disinfectant, Medical Devices | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LRJ), ordered by most recent decision date.
CONTROL III ELITE
FDA 510(k)
FDA Class 1
·General Hospital
PRO-PORTION CLEANER/DISINFECTANT
FDA 510(k)
FDA Class 1
·General Hospital
MICROSTAT 2
FDA 510(k)
FDA Class 1
·General Hospital
AMERSE 2
FDA 510(k)
FDA Class 1
·General Hospital
DISPATCH HOSPITAL CLEANER DISINFECTANT TOWELS WITH BLEACH
FDA 510(k)
FDA Class 1
·General Hospital
LOW PH PHENOLIC 256
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by Biotrol, USA, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K931141 | BIOTROL AMYLASE CNPG3 | May 26, 1993 | Substantially Equivalent |
| K921855 | BIOTROL BICARBONATE STANDARDS | Aug 3, 1992 | Substantially Equivalent |
| K921677 | BIOTROL MAGNESIUM (MAGON) | May 26, 1992 | Substantially Equivalent |
| K912795 | BIOTROL UIBC REAGENT | Aug 12, 1991 | Substantially Equivalent |
| K910721 | BIOTROL PROTEIN MULTILEVEL STANDARDS | May 6, 1991 | Substantially Equivalent |
| K905683 | BIOTROL LACTATE DEHYDROGENASE (L-P) | Mar 11, 1991 | Substantially Equivalent |
| K905280 | BIOTROL BILIRUBIN C & T CONTROL | Feb 4, 1991 | Substantially Equivalent |
| K894544 | BIOTROL RUB-E.I.A. TEST G | Aug 30, 1989 | Substantially Equivalent |
| K891061 | BIOTROL CALCIUM MONOREACTIF | Aug 10, 1989 | Substantially Equivalent |
| K891286 | BIOTROL CHEMISTRY URINE CONTROL | Apr 10, 1989 | Substantially Equivalent |