FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EAGLE 3000 SDS
K Number: K912471
·
Decision Jun 26, 1992
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
183
Applicant Total
19
Review Days
388
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Basic Information
- Device Name
- EAGLE 3000 SDS
- K Number
- K912471
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6880
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Amsco Co.
- Date Received
- June 4, 1991
- Decision Date
- June 26, 1992
- Product Code
- FLE
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FLE | Sterilizer, Steam | FDA class 2 | General Hospital |
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Other Clearances by Amsco Co.
| K Number | Device Name | ||
|---|---|---|---|
| K854922 | AMSCO POLARIS SL | Jan 24, 1986 | Substantially Equivalent |
| K833187 | HALL OSTEON | Oct 31, 1983 | Substantially Equivalent |
| K832945 | EAGLE 2000 STERILIZER SERIES GAS/AERA | Oct 19, 1983 | Substantially Equivalent |
| K832188 | HALL RECIPROCATOR | Aug 12, 1983 | Substantially Equivalent |
| K832187 | HALL OSCILLATOR | Aug 12, 1983 | Substantially Equivalent |
| K831086 | CEILING MOUNTED SUPPORT | Aug 12, 1983 | Substantially Equivalent |
| K832186 | HALL DRILL/REAMER | Aug 12, 1983 | Substantially Equivalent |
| K831309 | DELIVERY 4 TABLE | Jun 15, 1983 | Substantially Equivalent |
| K823360 | SURGICAL LIGHT | Dec 3, 1982 | Substantially Equivalent |
| K811242 | DISPOSABLE STERILIZATION WRAP | May 21, 1981 | Substantially Equivalent |