FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INSPIREASE(R), DRUG DELIVERY SYSTEM
K Number: K873793
·
Decision Oct 13, 1987
Classifications
1
FEI Numbers
140
Registration Numbers
140
Same Product Code
61
Applicant Total
2
Review Days
26
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Basic Information
- Device Name
- INSPIREASE(R), DRUG DELIVERY SYSTEM
- K Number
- K873793
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5640
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Key Pharmaceuticals, Inc.
- Date Received
- September 17, 1987
- Decision Date
- October 13, 1987
- 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 |
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Other Clearances by Key Pharmaceuticals, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K832037 | INSPIREASE | Aug 16, 1983 | Substantially Equivalent |