FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACCESSORY TO CLINICAL ELECTRONIC THERMOMETER
K Number: K890823
·
Decision May 5, 1989
Classifications
1
FEI Numbers
488
Registration Numbers
488
Same Product Code
797
Applicant Total
39
Review Days
77
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Basic Information
- Device Name
- ACCESSORY TO CLINICAL ELECTRONIC THERMOMETER
- K Number
- K890823
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2910
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Sheridan Catheter Corp.
- Date Received
- February 17, 1989
- Decision Date
- May 5, 1989
- Product Code
- FLL
- 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 |
|---|---|---|---|
| FLL | Continuous Measurement Thermometer | FDA class 2 | General Hospital |
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Other Clearances by Sheridan Catheter Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K922894 | LAZER-TRACH TRACHEAL TUBE | May 7, 1993 | Substantially Equivalent |
| K897046 | LASER RESISTANT TRACHEAL TUBE | Mar 23, 1990 | Substantially Equivalent |
| K884765 | CLINICAL ELECTRONIC THERMOMETERS | Feb 16, 1989 | Substantially Equivalent |
| K882918 | KIM NASO-INTESTINAL TUBE | Dec 5, 1988 | Substantially Equivalent |
| K882127 | CLINICAL ELECTRONIC THERMOMETERS | Aug 4, 1988 | Substantially Equivalent |
| K881368 | CLINICAL ELECTONIC THERMOMETERS | Jul 13, 1988 | Substantially Equivalent |
| K881293 | SHERIDAN ELECTROSURGERY PROTECTION FILTER | Jun 16, 1988 | Substantially Equivalent |
| K881873 | INTRODUCTION/DRAINAGE CATHETER & ACCESS | May 18, 1988 | Substantially Equivalent |
| K880960 | NDYAG LASER TRACHEAL TUBE | Apr 29, 1988 | Substantially Equivalent |
| K875226 | ESOPHAGEAL OBTURATOR/TRACHEAL TUBE | Jan 19, 1988 | Substantially Equivalent |