FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LEAD APRON
K Number: K931269
·
Decision Jun 2, 1993
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
5
Applicant Total
5
Review Days
86
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Basic Information
- Device Name
- LEAD APRON
- K Number
- K931269
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.6500
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Bt Medical Co., Inc.
- Date Received
- March 8, 1993
- Decision Date
- June 2, 1993
- Product Code
- EAJ
- 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 |
|---|---|---|---|
| EAJ | Apron, Leaded | FDA class 1 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EAJ), ordered by most recent decision date.
RINN PROTECTIVE X-RAY APRON AND PROTECTIVE COLLAR
FDA 510(k)
FDA Class 1
·Radiology
X-RAY APRON
FDA 510(k)
FDA Class 1
·Radiology
LEAD APRON CADDY
FDA 510(k)
FDA Class 1
·Radiology
LEADED X-RAY APRON
FDA 510(k)
FDA Class 1
·Radiology
THYROID PROTECTIVE COLLAR
FDA 510(k)
FDA Class 1
·Radiology
Other Clearances by Bt Medical Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K931268 | URETERAL COMPRESSION DEVICE | Jul 19, 1993 | Substantially Equivalent |
| K930885 | PNEUMATIC COMPRESSION DEVICE | Jul 13, 1993 | Substantially Equivalent |
| K915321 | BTM-200 (PROPOSED) POWERED MUSCLE STIMULATOR | Jul 17, 1992 | Substantially Equivalent |
| K914999 | BTM-100 POWERED MUSCLE STIMULATOR (PROPOSED) | Apr 23, 1992 | Substantially Equivalent |