FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INSPIREASE
K Number: K832037
·
Decision Aug 16, 1983
Classifications
1
FEI Numbers
140
Registration Numbers
140
Same Product Code
61
Applicant Total
2
Review Days
53
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
- INSPIREASE
- K Number
- K832037
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5640
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Key Pharmaceuticals, Inc.
- Date Received
- June 24, 1983
- Decision Date
- August 16, 1983
- 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
MEDSHIELD/AEROCHAMBER
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
Other Clearances by Key Pharmaceuticals, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K873793 | INSPIREASE(R), DRUG DELIVERY SYSTEM | Oct 13, 1987 | Substantially Equivalent |