Atlas FDA

NOSECLIP FOR RESP. CARE & PULMON. FUNC.

FDA 510(k) clearance K770015 · decided 1977-03-16

Clearance details

K-number
K770015
Device name
NOSECLIP FOR RESP. CARE & PULMON. FUNC.
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
Decision
Substantially Equivalent
Date received
1977-01-03
Decision date
1977-03-16
Days to decision
72 days
Clearance type
Traditional
Product code
BXJ
Device class
1
Regulation number
868.6225
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Washington, DC, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
MEDIPART DISPOS. NOSE CLIP MP-2001 (K853578)Medipart Jerry Alexander1985-10-29
NOSECLIP #6118 (K810339)Todd Industries, Inc.1981-03-17
NOSE CLIP (K760461)Inspiron Corp.1976-08-26

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
OXYCELL (N5798/S007)Bd Becton Dickinson Vacutainer Systems Preanalytic1995-07-24
OXYCEL OXIDIZED (N5798/S005)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-02-08
OXYCELL (N5798/S006)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-02-08
MINI BALLOON (P780011/S012)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-10-30
MINI BALLOON (P780011/S011)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-10-18
MINI BALLOON (P780011/S010)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-01-29
MINI BALLOON (P780011/S007)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-01-23
BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC (P800030/S006)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-11-05