FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NYSTYMOGRAPH ACCESS
K Number: K823111
·
Decision Nov 22, 1982
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
0
Applicant Total
94
Review Days
28
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Basic Information
- Device Name
- NYSTYMOGRAPH ACCESS
- K Number
- K823111
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3145
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Kelleher Corp.
- Date Received
- October 25, 1982
- Decision Date
- November 22, 1982
- Product Code
- GNN
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| GNN | Antisera, Neutralization, Coxsackievirus A 1-24, B 1-6 | FDA class 1 | Microbiology |
Other Clearances by Kelleher Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K822268 | NAGASHIMA NS-III ELECTRONYSTAGMOGRAPH | Jan 28, 1983 | Substantially Equivalent |
| K822618 | EMERGENCY TRACHEOSTOMY INSTRUMENT SET | Jan 28, 1983 | Substantially Equivalent |
| K823083 | ELECTROSURGICAL UNIT | Dec 7, 1982 | Substantially Equivalent |
| K822252 | ENT TREATMENT UNITS | Nov 22, 1982 | Substantially Equivalent |
| K822272 | HEAD MIRRORS W/HEAD LAMPS & HEAD BANDS | Nov 10, 1982 | Substantially Equivalent |
| K822017 | TYMPANOSTOMY TUBES & VARIOUS TYPES | Oct 27, 1982 | Substantially Equivalent |
| K822257 | VARIOUS TYPES OF LIGHT SOURCE HANDLES | Oct 26, 1982 | Substantially Equivalent |
| K822259 | LARYNGEAL SPATULAS | Oct 22, 1982 | Substantially Equivalent |
| K822004 | FACE SHIELDS | Oct 20, 1982 | Substantially Equivalent |
| K822185 | LARYNGEAL SYRINGE | Oct 18, 1982 | Substantially Equivalent |