FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INFANT SCALE DISPOSABLE LINER
K Number: K790659
·
Decision Apr 30, 1979
Classifications
1
FEI Numbers
573
Registration Numbers
573
Same Product Code
64
Applicant Total
13
Review Days
26
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Basic Information
- Device Name
- INFANT SCALE DISPOSABLE LINER
- K Number
- K790659
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6060
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Hydro-Med Products, Inc.
- Date Received
- April 4, 1979
- Decision Date
- April 30, 1979
- Product Code
- KME
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| KME | Bedding, Disposable, Medical | FDA class 1 | General Hospital |
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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 |
| 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 |