FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CAMERA COVER WITH TEAR TIP
K Number: K940152
·
Decision Oct 28, 1994
Classifications
1
FEI Numbers
63
Registration Numbers
63
Same Product Code
3
Applicant Total
13
Review Days
298
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Basic Information
- Device Name
- CAMERA COVER WITH TEAR TIP
- K Number
- K940152
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hydro-Med Products, Inc.
- Date Received
- January 3, 1994
- Decision Date
- October 28, 1994
- Product Code
- FEM
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FEM | Accessories, Photographic, For Endoscope (Exclude Light Sources) | FDA class 1 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FEM), ordered by most recent decision date.
PHOTOGRAPHIC EQUIPMENT
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
POLAROID INSTANT ENDOCAMERA
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
POLAROID LAND CAMERA FOR ENDOSCOPY
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
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 |
| K923099 | X-RAY DRAPES | Oct 15, 1992 | 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 |