FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HCMI X-RAY HIGH REQUENCY CHIROPRACTIC RADIOGRAPHIC
K Number: K022737
·
Decision Oct 22, 2002
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
355
Applicant Total
7
Review Days
64
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Basic Information
- Device Name
- HCMI X-RAY HIGH REQUENCY CHIROPRACTIC RADIOGRAPHIC
- K Number
- K022737
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Health Care Mfg., Inc.
- Date Received
- August 19, 2002
- Decision Date
- October 22, 2002
- Product Code
- KPR
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| KPR | System, X-Ray, Stationary | FDA class 2 | Radiology |
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Other Clearances by Health Care Mfg., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K022667 | HCMI X-RAY | Oct 22, 2002 | Substantially Equivalent |
| K952441 | LEGEND | Jun 19, 1995 | Substantially Equivalent |
| K951323 | VH-2000 | Jun 7, 1995 | Substantially Equivalent |
| K951382 | HLT 406 | Jun 1, 1995 | Substantially Equivalent |
| K944699 | ATT-300 | May 26, 1995 | Substantially Equivalent |
| K944329 | BACK SPECIALIST | Mar 15, 1995 | Substantially Equivalent |