FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABS
K Number: K951491
·
Decision Apr 24, 1995
Classifications
1
FEI Numbers
142
Registration Numbers
142
Same Product Code
46
Applicant Total
13
Review Days
24
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Basic Information
- Device Name
- DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABS
- K Number
- K951491
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5770
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Dale Medical Products, Inc.
- Date Received
- March 31, 1995
- Decision Date
- April 24, 1995
- Product Code
- CBH
- 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 |
|---|---|---|---|
| CBH | Device, Fixation, Tracheal Tube | FDA class 1 | Anesthesiology |
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Other Clearances by Dale Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K082241 | THE DALE ACE CONNECTOR (ACCESS CONTROLLER FOR ENTERAL), MODEL H84104751 | Oct 30, 2008 | Substantially Equivalent |
| K994300 | NASOGASTRIC TUBE HOLDER, MODEL 160 | Feb 10, 2000 | Substantially Equivalent |
| K964399 | DALE ENDOTRACHEAL TUBE HOLDER 270/280 | Jan 28, 1997 | Substantially Equivalent |
| K961693 | DALE GASTROSTOMY TUBE HOLDER | Jul 30, 1996 | Substantially Equivalent |
| K914245 | DALE(R) NASAL DRESSING HOLDER (PRODUCT NO. 600) | Dec 9, 1991 | Substantially Equivalent |
| K905231 | DALE VENTILATOR TUBING SUPPORT FOR TRACH. VENT. | Jan 14, 1991 | Substantially Equivalent |
| K894586 | DALE I.V. IDENTIFIER; PRODUCT #1125 | Aug 15, 1989 | Substantially Equivalent |
| K873311 | DALE I.V. CONNECT. LOCK & STABILIZER (STABILOK)220 | Nov 5, 1987 | Substantially Equivalent |
| K864897 | DALE VENIPUNCTURE TOURNIQUET, PRODUCT NO. 1335 | Jan 12, 1987 | Substantially Equivalent |
| K860583 | DALE HEAD BAND ANESTHESIA CIRCUIT TUBE HOLDER 1315 | Feb 21, 1986 | Substantially Equivalent |