FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LM2000A SURGICAL SUCTION MONITOR
K Number: K854359
·
Decision Mar 3, 1986
Classifications
1
FEI Numbers
276
Registration Numbers
276
Same Product Code
47
Applicant Total
5
Review Days
125
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Basic Information
- Device Name
- LM2000A SURGICAL SUCTION MONITOR
- K Number
- K854359
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Engineering, Inc.
- Date Received
- October 29, 1985
- Decision Date
- March 3, 1986
- Product Code
- KDQ
- 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 |
|---|---|---|---|
| KDQ | Bottle, Collection, Vacuum | FDA class 2 | General Hospital |
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Other Clearances by Engineering, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K881521 | MODIFIED SERVO SYRINGE | May 31, 1988 | Substantially Equivalent |
| K862749 | LS9000 SUCTION BIOPSY NEEDLE | Sep 15, 1986 | Substantially Equivalent |
| K862476 | LS3000 CANNULA UTERINE SUCTION | Jul 18, 1986 | Substantially Equivalent |
| K854844 | LS1000 SURGICAL ASPIRATOR II | Feb 12, 1986 | Substantially Equivalent for Some Indications |