FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MIST-EASE NEBULIZER
K Number: K844591
·
Decision Dec 13, 1984
Classifications
1
FEI Numbers
140
Registration Numbers
140
Same Product Code
61
Applicant Total
9
Review Days
17
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Basic Information
- Device Name
- MIST-EASE NEBULIZER
- K Number
- K844591
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5640
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- General Physiotherapy, Inc.
- Date Received
- November 26, 1984
- Decision Date
- December 13, 1984
- 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 General Physiotherapy, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K870939 | VIBRACARE | Apr 6, 1987 | Substantially Equivalent |
| K863383 | FACIAL MASSAGER, BATTERY POWERED | Sep 15, 1986 | Substantially Equivalent |
| K861834 | THERACUSHION MODEL 1000 | May 27, 1986 | Substantially Equivalent |
| K855129 | NEOCUSSOR (MASSAGER, BATTERY) POWERED | Jan 23, 1986 | Substantially Equivalent |
| K853710 | THERACUSHION | Jan 3, 1986 | Substantially Equivalent |
| K852944 | FLEXIMATIC MASSAGER | Sep 5, 1985 | Substantially Equivalent |
| K850047 | SANYO ELECTRONIC MUSCLE STIMULATORS | Mar 5, 1985 | Substantially Equivalent |
| K810244 | PORTA-PULS MUSCLE STIMULATOR | Feb 26, 1981 | Substantially Equivalent |