FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MECONIUM SUCTION TRAP
K Number: K862181
·
Decision Aug 13, 1986
Classifications
1
FEI Numbers
245
Registration Numbers
245
Same Product Code
115
Applicant Total
2
Review Days
65
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Basic Information
- Device Name
- MECONIUM SUCTION TRAP
- K Number
- K862181
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.6810
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Michael Reese Hospital and Medical Center
- Date Received
- June 9, 1986
- Decision Date
- August 13, 1986
- Product Code
- BSY
- 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 |
|---|---|---|---|
| BSY | Catheters, Suction, Tracheobronchial | FDA class 1 | Anesthesiology |
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Other Clearances by Michael Reese Hospital and Medical Center
| K Number | Device Name | ||
|---|---|---|---|
| K862182 | AMNIOINFUSION CATHETER | Aug 25, 1986 | Substantially Equivalent |