FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HEADSTRAP
K Number: K854537
·
Decision Dec 3, 1985
Classifications
1
FEI Numbers
93
Registration Numbers
93
Same Product Code
5
Applicant Total
29
Review Days
20
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Basic Information
- Device Name
- HEADSTRAP
- K Number
- K854537
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5560
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Life Design Systems, Inc.
- Date Received
- November 13, 1985
- Decision Date
- December 3, 1985
- Product Code
- BTK
- 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 |
|---|---|---|---|
| BTK | Strap, Head, Gas Mask | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BTK), ordered by most recent decision date.
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MEDIPART FACE MASK HEADSTRAP MP-9100
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HEAD STRAP
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HEADSTRAP
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·Anesthesiology
Other Clearances by Life Design Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K913714 | MODIFICATION MANUAL PULMON RESUSCITOR/PULMANEX(TM) | Dec 1, 1992 | Substantially Equivalent |
| K885313 | HUMIDI-FLEX TM | Oct 11, 1989 | Substantially Equivalent |
| K893030 | CHILD SIZE - FILTER FLEX (TM) | Sep 18, 1989 | Substantially Equivalent |
| K892862 | FLEX-CUP PERCUSSOR | May 25, 1989 | Substantially Equivalent |
| K892221 | PULMONARY RESUSCITATOR, MODIFICATION | May 18, 1989 | Substantially Equivalent |
| K890011 | OXYGEN CONNECTOR AND OXYGEN DELIVERY TUBING | Mar 20, 1989 | Substantially Equivalent |
| K890108 | MODIFIED CUSHION-FLEX(TM) | Jan 24, 1989 | Substantially Equivalent |
| K884387 | CUSHION FLEX(TM) | Nov 17, 1988 | Substantially Equivalent |
| K884068 | PULMANEX TM (NEO-NATAL SIZE) | Nov 16, 1988 | Substantially Equivalent |
| K873179 | HEATER WIRE BREATHING CIRCUIT | Mar 31, 1988 | Substantially Equivalent |