FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AEROSOL DELIVERY SYSTEMS
K Number: K920842
·
Decision May 15, 1992
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
5
Applicant Total
27
Review Days
81
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Basic Information
- Device Name
- AEROSOL DELIVERY SYSTEMS
- K Number
- K920842
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.5220
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hospitak, Inc.
- Date Received
- February 24, 1992
- Decision Date
- May 15, 1992
- Product Code
- LRD
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| LRD | Applicator, Ent Drug | FDA class 1 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LRD), ordered by most recent decision date.
AROMAPATCH
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AMSCO STERILE RECOVERIES SURGICAL PACKS
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·Ear, Nose, Throat
MISTASSIST
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
THE EXPANDACELL EAR PACK
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
SURGICAL TRAY (STERILE)
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
Other Clearances by Hospitak, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K955483 | TRACH MASK MODEL (245, 246) | Feb 28, 1996 | Substantially Equivalent |
| K954787 | ILLUMINATOR | Jan 31, 1996 | Substantially Equivalent |
| K953620 | WARM N WET HMEF W/LUER ADAPTER | Aug 25, 1995 | Substantially Equivalent |
| K953619 | WARM N WET HME W/LUER ADAPTER | Aug 25, 1995 | Substantially Equivalent |
| K915750 | DISPOSABLE BACTERIAL BREATHNG FILTER | Nov 30, 1994 | Substantially Equivalent |
| K915228 | DISPOSABLE CO2 GAS SAMPLING/OXYGEN DELIVERY CANNUL | Feb 11, 1992 | Substantially Equivalent |
| K873286 | DISPOSABLE, MANUAL PULMONARY RESUSCITATOR | Oct 26, 1987 | Substantially Equivalent |
| K853600 | INFLATABLE AIR SPLINTS | Sep 19, 1985 | Substantially Equivalent |
| K844328 | OXYGEN CONCENTRATOR | Dec 4, 1984 | Substantially Equivalent |
| K843212 | LOW PRESSURE ALARM FOR OXYGEN CYLINDER | Sep 19, 1984 | Substantially Equivalent |