FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
SENSE TECHNOLOGY INC. FRAS, SENSE TECHNOLOGY INC. PULSTAR
K Number: K973914
·
Decision Jun 30, 1998
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
31
Applicant Total
2
Review Days
259
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Basic Information
- Device Name
- SENSE TECHNOLOGY INC. FRAS, SENSE TECHNOLOGY INC. PULSTAR
- K Number
- K973914
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sense Technology, Inc.
- Date Received
- October 14, 1997
- Decision Date
- June 30, 1998
- Product Code
- LXM
- Advisory Committee
- Unknown
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| LXM | Manipulator, Plunger-Like Joint | FDA unclassified | Unknown |
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Other Clearances by Sense Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K940085 | FORCE RECORDING AND ANALYSIS SYSTEM, MODEL 01 | Dec 7, 1994 | Substantially Equivalent |