FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TDP CQ-27 HEAT LAMP
K Number: K003538
·
Decision Jun 4, 2001
Classifications
1
FEI Numbers
462
Registration Numbers
462
Same Product Code
228
Applicant Total
11
Review Days
200
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Basic Information
- Device Name
- TDP CQ-27 HEAT LAMP
- K Number
- K003538
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5500
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lhasa Medical, Inc.
- Date Received
- November 16, 2000
- Decision Date
- June 4, 2001
- Product Code
- ILY
- Advisory Committee
- Physical Medicine
- 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 |
|---|---|---|---|
| ILY | Lamp, Infrared, Therapeutic Heating | FDA class 2 | Physical Medicine |
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Other Clearances by Lhasa Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K031250 | DBC PRESS ACUPUNCTURE NEEDLES | Jul 15, 2003 | Substantially Equivalent |
| K031060 | NANO TECH AND SUPER NANO ACUPUNCTURE NEEDLES | Jul 11, 2003 | Substantially Equivalent |
| K023787 | TAI-CHI AND MASTER ACUPUNCTURE NEEDLES | Feb 14, 2003 | Substantially Equivalent |
| K013197 | WS-501 HEAT LAMP | Aug 29, 2002 | Substantially Equivalent |
| K003760 | TAI-CHI ACUPUNCTURE NEEDLES | Feb 6, 2001 | Substantially Equivalent |
| K964529 | CW ACUPUNCTURE NEEDLES | Jan 30, 1997 | Substantially Equivalent |
| K964411 | TAKI ACUPUNCTURE NEEDLES | Dec 31, 1996 | Substantially Equivalent |
| K963299 | HWA-TO ACUPUNCTURE NEEDLES | Sep 30, 1996 | Substantially Equivalent |
| K963300 | DBC ACUPUNTURE NEEDLES(SEVERAL TYPES ARE DESCRIBED ON THE FOLLOWING PAGES) | Sep 23, 1996 | Substantially Equivalent |
| K962916 | HUA-XIA ACUPUNCTURE NEEDLES | Aug 23, 1996 | Substantially Equivalent |