FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NEBULIZER, MEDICINAL
K Number: K802430
·
Decision Oct 23, 1980
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
1
Applicant Total
43
Review Days
17
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Basic Information
- Device Name
- NEBULIZER, MEDICINAL
- K Number
- K802430
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.5220
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Dhd Medical Products Div. Diemolding Corp.
- Date Received
- October 6, 1980
- Decision Date
- October 23, 1980
- Product Code
- EPN
- 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 |
|---|---|---|---|
| EPN | Pump, Nebulizer, Manual | FDA class 1 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EPN), ordered by most recent decision date.
View allOther Clearances by Dhd Medical Products Div. Diemolding Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K883988 | NON-REBREATHING TEE PIECE (NRTP) | Oct 7, 1988 | Substantially Equivalent |
| K881935 | MICROCIRRUS MEDICAL NEBULIZER | Jun 22, 1988 | Substantially Equivalent |
| K881178 | CUFFCHECK | Apr 14, 1988 | Substantially Equivalent |
| K873498 | INSPIRATORY FORCE MONT KIT/MANIFOLD/METER/TUBING | Mar 9, 1988 | Substantially Equivalent |
| K874047 | ASTHMAKIT | Feb 29, 1988 | Substantially Equivalent |
| K873447 | DISPOSABLE CONDENSATE BOTTLE FOR 7200 VENTILATOR | Oct 30, 1987 | Substantially Equivalent |
| K860873 | VENTURI MASK/ADULT & PAEDIATRIC | Mar 20, 1986 | Substantially Equivalent |
| K860879 | DISPOSABLE VENTILATOR CIRCUITS | Mar 20, 1986 | Substantially Equivalent |
| K860880 | VENTILATOR CIRCUITS (VARIOUS TYPES) | Mar 20, 1986 | Substantially Equivalent |
| K860878 | BRITISH BREATHING CIRCUIT SYSTEM | Mar 20, 1986 | Substantially Equivalent |