FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MEDISHIELD CERVICAL COLLAR
K Number: K770910
·
Decision May 25, 1977
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
2
Applicant Total
6
Review Days
6
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MEDISHIELD CERVICAL COLLAR
- K Number
- K770910
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.5890
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Fraser Sweatman, Inc.
- Date Received
- May 19, 1977
- Decision Date
- May 25, 1977
- Product Code
- HSS
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| HSS | Halter, Head, Traction | FDA class 1 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HSS), ordered by most recent decision date.
ORTHOPEDIC SOFT GOODS
FDA 510(k)
FDA Class 1
·Orthopedic
SPLIT CERVICAL COLLAR/HEAD HALTER
FDA 510(k)
FDA Class 1
·Orthopedic
Other Clearances by Fraser Sweatman, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K771299 | EMERGENCY OXYGEN RESUSCITATOR | Aug 4, 1977 | Substantially Equivalent |
| K770911 | MEDISHIELD JORDON LIFTING FRAME | Jun 27, 1977 | Substantially Equivalent |
| K761140 | FRASER SWEATMAN'S DOUBLE MASK | Dec 9, 1976 | Substantially Equivalent |
| K760766 | PRE-SET 50/50 NITROUS OXIDE/OXYGEN MIXER | Oct 8, 1976 | Substantially Equivalent |
| K760076 | ABSORBER, ANESTHESIA CIRCLE SYS, CO2 | Jul 16, 1976 | Substantially Equivalent |