FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LOUISVILLE LABS OXYGEN HEAD TENT
K Number: K955535
·
Decision Jul 1, 1996
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
68
Applicant Total
12
Review Days
209
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Basic Information
- Device Name
- LOUISVILLE LABS OXYGEN HEAD TENT
- K Number
- K955535
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5470
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Louisville Laboratories, Inc.
- Date Received
- December 5, 1995
- Decision Date
- July 1, 1996
- Product Code
- CBF
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| CBF | Chamber, Hyperbaric | FDA class 2 | Anesthesiology |
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Other Clearances by Louisville Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K980123 | CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SET | Mar 9, 1998 | Substantially Equivalent |
| K971796 | LAPAROTOMY BLADDER NECK SUSPENSION KIT WITH BONE ANCHORS | Aug 12, 1997 | Substantially Equivalent |
| K971791 | VAGINAL SUTURING KIT FOR LAPAROTOMY BLADDER NECK SUSPENSION | Jul 30, 1997 | Substantially Equivalent |
| K971802 | VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION | Jul 30, 1997 | Substantially Equivalent |
| K971797 | LAPAROSCOPIC BLADDER NECK SUSPENSION KIT | Jul 22, 1997 | Substantially Equivalent |
| K971801 | LAPAROTOMY BLADDER NECK SUSPENSION KIT | Jul 22, 1997 | Substantially Equivalent |
| K963076 | LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAY | Apr 4, 1997 | Substantially Equivalent |
| K960882 | CONTROL SYRINGE | Jul 8, 1996 | Substantially Equivalent |
| K946282 | UNIVERSAL URETHRAL CATHETER | Mar 31, 1995 | Substantially Equivalent |
| K932979 | EXTERNAL STABILITY PAD | Nov 2, 1993 | Substantially Equivalent |