FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
X-RAY DRAPES
K Number: K923099
·
Decision Oct 15, 1992
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
2
Applicant Total
13
Review Days
112
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Basic Information
- Device Name
- X-RAY DRAPES
- K Number
- K923099
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.6500
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Hydro-Med Products, Inc.
- Date Received
- June 25, 1992
- Decision Date
- October 15, 1992
- Product Code
- IWQ
- 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 |
|---|---|---|---|
| IWQ | Curtain, Protective, Radiographic | FDA class 1 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IWQ), ordered by most recent decision date.
MAVIG LOWER BODY PROTECTION SYSTEMS, ASSEMBLY MODELS 6265, 6266, 6267, 6268, 6269/0, 629/1, AND 6269/2
FDA 510(k)
FDA Class 1
·Radiology
TECHTON PROTECTIVE PAD
FDA 510(k)
FDA Class 1
·Radiology
Other Clearances by Hydro-Med Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K944198 | SURGICAL MICROSCOPE DRAPE | Nov 27, 1994 | Substantially Equivalent |
| K940151 | ULTRASOUND PROBE DRAPE | Nov 14, 1994 | Substantially Equivalent |
| K934630 | UNIVERSAL VIDEO/LASER ARM DRAPE | Oct 28, 1994 | Substantially Equivalent |
| K940152 | CAMERA COVER WITH TEAR TIP | Oct 28, 1994 | Substantially Equivalent |
| K863872 | TAMPER HAMPER | Feb 10, 1987 | Substantially Equivalent |
| K853281 | EASYTOP | Aug 21, 1985 | Substantially Equivalent |
| K842304 | THE PATHFINDER | Aug 1, 1984 | Substantially Equivalent |
| K834407 | STERILE DISPOSABLE SPINAL NEEDLES | Mar 19, 1984 | Substantially Equivalent |
| K812405 | STERILE TV CAMERA & CORD COVER | Oct 20, 1981 | Substantially Equivalent |
| K790659 | INFANT SCALE DISPOSABLE LINER | Apr 30, 1979 | Substantially Equivalent |