FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL 2500 PNEUMATIC PERCUSSOR
K Number: K802399
·
Decision Oct 23, 1980
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
57
Applicant Total
7
Review Days
21
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Basic Information
- Device Name
- MODEL 2500 PNEUMATIC PERCUSSOR
- K Number
- K802399
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5665
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Medical Equipment Development Co., Inc.
- Date Received
- October 2, 1980
- Decision Date
- October 23, 1980
- Product Code
- BYI
- 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 |
|---|---|---|---|
| BYI | Percussor, Powered-Electric | FDA class 2 | Anesthesiology |
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Other Clearances by Medical Equipment Development Co., Inc.
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|---|---|---|---|
| K911973 | LINEAR ACCELERATOR COLLIMATOR | Oct 15, 1992 | Substantially Equivalent |
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| K895537 | MODIFIED MEMORY RETRACTOR ARM | Sep 22, 1989 | Substantially Equivalent |
| K893911 | MED-TECH RADIOLUCENT HEAD FIXATION SYSTEM | Aug 29, 1989 | Substantially Equivalent |
| K874829 | MEDCO MEMORY RETRACTOR SYSTEM | Mar 24, 1988 | Substantially Equivalent |
| K874833 | ARC ADAPTER ASSEMBLY | Mar 3, 1988 | Substantially Equivalent |