FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PHILLY INFANT BOLT
K Number: K820151
·
Decision Jan 28, 1982
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
58
Applicant Total
6
Review Days
9
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Basic Information
- Device Name
- PHILLY INFANT BOLT
- K Number
- K820151
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1460
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Philadelphia Medical Specialties
- Date Received
- January 19, 1982
- Decision Date
- January 28, 1982
- Product Code
- GWN
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| GWN | Nystagmograph | FDA class 2 | Neurology |
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Other Clearances by Philadelphia Medical Specialties
| K Number | Device Name | ||
|---|---|---|---|
| K840999 | PHILLY INFANT BOLT | Apr 4, 1984 | Substantially Equivalent |
| K834148 | PHILLY BOLTS | Feb 10, 1984 | Substantially Equivalent |
| K823459 | PHILLY BOLT ADULT PROCEDURE KIT | Dec 22, 1982 | Substantially Equivalent |
| K822636 | CLASS II DEVICE FOR I.C.P. MONITORING | Sep 14, 1982 | Substantially Equivalent |
| K813440 | PHILLY BOLT | Dec 18, 1981 | Substantially Equivalent |