FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇰 Denmark
TCM400
K Number: K001866
·
Decision Dec 7, 2000
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
1
Applicant Total
2
Review Days
170
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Basic Information
- Device Name
- TCM400
- K Number
- K001866
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 868.2500
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Radiometer Medical A/S
- Date Received
- June 20, 2000
- Decision Date
- December 7, 2000
- Product Code
- LPP
- 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 |
|---|---|---|---|
| LPP | Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LPP), ordered by most recent decision date.
View allOther Clearances by Radiometer Medical A/S
| K Number | Device Name | ||
|---|---|---|---|
| K002290 | ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS) | Sep 13, 2000 | Substantially Equivalent |