FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MEDSHIELD/AEROCHAMBER
K Number: K961455
·
Decision Jul 25, 1996
Classifications
1
FEI Numbers
140
Registration Numbers
140
Same Product Code
61
Applicant Total
12
Review Days
100
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
- MEDSHIELD/AEROCHAMBER
- K Number
- K961455
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5640
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Diemolding Corp.
- Date Received
- April 16, 1996
- Decision Date
- July 25, 1996
- Product Code
- CCQ
- 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 |
|---|---|---|---|
| CCQ | Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CCQ), ordered by most recent decision date.
EZ SPRAY
FDA 510(k)
FDA Class 1
·Anesthesiology
E-Z SPACER MASK (SMALL)
FDA 510(k)
FDA Class 1
·Anesthesiology
MDI TUTOR
FDA 510(k)
FDA Class 1
·Anesthesiology
SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST SPIROMETRY AIRWAY, MODEL NUMBER SA-100
FDA 510(k)
FDA Class 1
·Anesthesiology
SALINE SOLUTION- STERILE
FDA 510(k)
FDA Class 1
·Anesthesiology
MODIFIED AEROCHAMBER WITH MASK
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by Diemolding Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K962749 | THERAPEP W/MOUTHPIECE, W/PEDIATRIC MASK, W/SMALL MASK, W/LARGE MASK, RESISTOR/PORT/MOUTHPIECE, RESISTOR/PORT | Oct 10, 1996 | Substantially Equivalent |
| K902713 | ACCESS. KIT FOR THE BIOSURGE SYNCHRONOUS AUTOTRANS | Jul 25, 1990 | Substantially Equivalent |
| K902114 | CUFF-MATE 2 ENDOTRACHEAL CUFF INFLATOR & MONITOR | Jul 18, 1990 | Substantially Equivalent |
| K900754 | RESPIREX 2 | Mar 15, 1990 | Substantially Equivalent |
| K893791 | BREATHING MOUTHPIECE | Jun 23, 1989 | Substantially Equivalent |
| K781759 | RESCAL | Nov 27, 1978 | Substantially Equivalent |
| K780750 | O2 CONNECTOR | Jul 27, 1978 | Substantially Equivalent |
| K770369 | VACON TM | Mar 1, 1977 | Substantially Equivalent |
| K760931 | I.V. DRIP MONITOR ALARM DEVICE, MONIFLO | Jan 5, 1977 | Substantially Equivalent |
| K760636 | ORTHOMIX | Oct 5, 1976 | Substantially Equivalent |