FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PHONATORY FUNCTION ANALYZER PS-77
K Number: K832678
·
Decision Mar 7, 1984
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
6
Applicant Total
12
Review Days
211
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Basic Information
- Device Name
- PHONATORY FUNCTION ANALYZER PS-77
- K Number
- K832678
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.2885
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Kells Medical, Inc.
- Date Received
- August 9, 1983
- Decision Date
- March 7, 1984
- Product Code
- BXP
- 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 |
|---|---|---|---|
| BXP | Transducer, Gas Flow | FDA class 1 | Anesthesiology |
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|---|---|---|---|
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| K890094 | EVA EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET | May 24, 1989 | Substantially Equivalent |
| K861972 | DERMISTRIP | Jun 27, 1986 | Substantially Equivalent for Some Indications |
| K844463 | DERMIDRESS | Jan 8, 1985 | Substantially Equivalent |
| K844072 | DERMIZIP SKIN CLOSURE DEVICE | Nov 5, 1984 | Substantially Equivalent |
| K832667 | LUCAE'S EAR & NASAL APPLICATORS | Sep 29, 1983 | Substantially Equivalent |
| K823118 | SAY | Jan 7, 1983 | Substantially Equivalent |
| K823226 | SN-100 DOCTOR'S ROUND | Nov 22, 1982 | Substantially Equivalent |