FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CENTURION(TM) MIXER
K Number: K884879
·
Decision Feb 9, 1989
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
187
Applicant Total
14
Review Days
80
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
- CENTURION(TM) MIXER
- K Number
- K884879
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5160
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Matrix Medica, Inc.
- Date Received
- November 21, 1988
- Decision Date
- February 9, 1989
- Product Code
- BSZ
- 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 |
|---|---|---|---|
| BSZ | Gas-Machine, Anesthesia | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BSZ), ordered by most recent decision date.
Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)
FDA 510(k)
FDA Class 2
·Anesthesiology
Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration)
FDA 510(k)
FDA Class 2
·Anesthesiology
Atlan
FDA 510(k)
FDA Class 2
·Anesthesiology
Carestation 750/750c
FDA 510(k)
FDA Class 2
·Anesthesiology
A8, A9 Anesthesia System
FDA 510(k)
FDA Class 2
·Anesthesiology
Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Matrix Medica, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K961536 | FLEXSCOPE | Sep 18, 1996 | Substantially Equivalent |
| K923693 | KLORMAN | Jan 23, 1996 | Substantially Equivalent |
| K921982 | MATRX HOPE(R) 5 RESUSCITATOR | Oct 28, 1994 | Substantially Equivalent |
| K915353 | MATRX MEDICAL MAXIMIZER 1000 AND 2000 VACUUM PUMP | Dec 27, 1991 | Substantially Equivalent |
| K912661 | MATRX, PYRAMID TRIANGLE BANDAGE | Aug 21, 1991 | Substantially Equivalent |
| K900551 | MATRX DISPOSABLE NON-INVASIVE GELLED PACING ELEC. | May 9, 1990 | Substantially Equivalent |
| K895533 | LIFE DEFENSE PLUS(TM), DEFIBRILLATOR/MONITOR/PACER | Jan 26, 1990 | Substantially Equivalent |
| K895525 | MATRX BATTERY CHARGER/DEFIBRILLATOR TESTER | Jan 26, 1990 | Substantially Equivalent |
| K893219 | MATRX DENTAL UNIT | Aug 7, 1989 | Substantially Equivalent |
| K883833 | NITRONOX(R), FIRST RESPONSE NITRONOX(TM) | Feb 17, 1989 | Substantially Equivalent |